Cato Research employs more than 300 dedicated professionals, including a high percentage of full-time physicians and doctoral-level scientists. Our senior staff members average more than 20 years of experience in pharmaceutical development, including expertise in clinical research, medicine, science, statistics, regulatory affairs, and finance.
Cato Research is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them.
As an expanding contract research organization, Cato Research is constantly on the move, growing and keeping up-to-date with the latest advances and technology in the industry. We host events worldwide, between our global offices. We attend industry conferences and other life science events. Join us as we continue to develop, produce and add value to our partnered teams.
Cato Research has in-house capabilities to assist sponsors with all aspects of the drug development process, including the following activities:
Regulatory assessments and strategy development
Interactions with regulators, including authoring and managing submissions
Preclinical/toxicology development programs; study management and monitoring
Pharmacokinetic study design and management
Phase 1 through Phase 4 clinical study design, implementation, trial management, and monitoring services
Statistical analyses and integrated statistical/clinical study reports
Program and project management
Safety and pharmacovigilance
Chemistry, manufacturing, and control programs
Quality Clinical Trial Oversight
Quality assurance, including audit and compliance activities for GCP, GLP and GMP
Due diligence activities for emerging technologies
Our expertise in devising regulatory and product development strategies is directed by senior staff members who have many years of experience interacting with the US Food and Drug Administration (FDA), Health Canada (HC), and other international regulatory agencies.
Cato Research has detailed knowledge of the intricacies of regulatory agencies and an established reputation that helps to promote and coordinate constructive formal and informal regulatory agency meetings and interactions for sponsors.
CATO’s integrated regulatory and clinical competencies offers a unique resource that focuses on your corporate objectives and that can deliver results.
An overview of our services is detailed alphabetically below:
Chemistry, manufacturing, and controls (CMC) is the part of pharmaceutical development that deals with the nature and properties of the drug substance and drug product, the manner in which both are made, and the manner by which the manufacturing process shown to be in control to the satisfaction of regulators.
Cato Research employs a diverse group of seasoned CMC scientists with expertise in the following: chemical synthesis; biopharmaceutical manufacturing; drug product and analytical development; medical devices/diagnostics; supply chain strategy; manufacturing operations; quality control (QC); quality assurance; and regulatory affairs. Our focus is to ensure the quality, consistency, and technical validity of the CMC program, to conform to the various global regulatory requirements and quality standards, and to provide the appropriate level of detail for the specific submission. CATO's CMC experts combine in-depth technical knowledge of product development with risk-based submission content and regulatory strategies for all the review and approval process.
The breadth of CATO's pharmaceutical expertise provides you with a single, integrated source for efficient problem-solving strategies and scientific expertise. Whether your needs are comprehensive or tightly focused on a specific project, our experienced CMC team will help keep your development program on track. In addition to offering advice, we provide hands-on, flexible resources and expanded operational capabilities to implement compliant drug development strategies and timelines.
Why We Do It Better
Guided by its expert CMC team, CATO helps clients navigate through all phases of development and the commercialization process.
Our clients can choose from our full suite of services and products or can select a specific offering at any point along the drug development timeline.
We have a proven track record in delivering results and in establishing solid and dynamic customer relationships, and have a strong commitment to enhance our skills and service offerings as our customers’ needs grow.
What we offer
Cato Research combines drug development with regulatory affairs expertise to ensure that your CMC program not only produces GMP-compliant clinical trial material, but also delivers the data and information required to meet reviewer expectations for each stage of clinical development.
Synthetic route strategy development
Synthetic route selection
Regulatory starting material definition
Synthesis, fermentation and cell culture processes
Isolation and purification processes
Analytical and Bioanalytical
Analytical and bioanalytical strategy development
Analytical and bioanalytical testing/validation
Drug Product Development
Analytical methods development
Regulatory-compliance gap analysis of product development plans and submissions
Regulatory evaluation and strategy
Authoring and/or reviewing regulatory filings
Participation and support in meetings with regulatory authorities
Preapproval inspection preparation
Supply Chain and Manufacturing Strategy
Technology transfer planning and management
Vendor and facility selection
Vendor and facility audits
Manufacturing process development and validation
Process assessment and optimization
Clinical Trial Material
Planning and oversight of CTM packaging and labeling activities
Management of CTM supply to minimize waste
Assistance with blinding and randomization protocols
The Cato Research Clinical Strategy group works with clients to develop and implement clinical development strategies that will lead to successful regulatory submissions for new drugs, biologics, medical devices, and other life science products. Our scope of services includes the following:
Clinical Development Plans
The critical components of a strategic clinical development plan that will lead to the approval of new drugs, biologics, and medical devices are identified. This includes, but is not limited to, the following activities:
Formulate gap analyses
Identify critical success factors
Evaluate current and new drugs in different therapeutic areas
Develop comprehensive clinical development plans
The appropriate components of clinical studies that will achieve the goals of the study and the objectives of the clinical development program are identified. This includes the following activities:
Identify appropriate study endpoints, design, patient populations, and methodology
Conduct feasibility studies to determine appropriate and timely approach to conducting clinical studies
Prepare clinical study documents, including study protocols, investigator’s brochures, study procedure manuals, and all other associated documents required for a clinical study
Prepare clinical study reports, PK reports and study summaries
Reports and Documents for Regulatory Submission
The appropriate documents are prepared based on the clinical strategies and clinical studies to submit to regulatory agencies. This includes preparing the following types of documents:
IND and IDE submissions
Clinical sections of NDA, BLA, and PMA submissions
FDA briefing documents
Premarketing and postmarketing annual and periodic safety reports (e.g., annual reports, DSURs, PSRs, PBRERs, PSURs)
Responses to clinical-related queries from regulatory agencies
Variation reports and clinical overviews for EMA submissions
Documents in Support of Clinical Development Programs
Documents to support development programs for drugs, biologics, and devices, including the following, are developed and prepared:
Review monographs and white papers
Systematic literature reviews and critical analyses of new drugs, therapeutic areas, and competitive analyses
What Distinguishes Clinical Strategy Scientists at Cato Research from Others?
All the clinical strategy scientists and medical writers at CATO have doctorate-level degrees (Ph.D.'s or Pharm.D.'s). Our scientists have had significant experience preparing documents for submission to global regulatory agencies. Our scientists have published manuscripts in the academic literature and have presented at scientific conferences. With this experience, CATO’s clinical scientists and medical writers have the necessary skills and knowledge to ensure that clinical trial projects and appropriate clinical strategies are implemented to lead to successful outcomes. This also ensures that the protocols and clinical development plans provided by Cato Research are of the highest quality. The combined experience of our clinical strategy scientists spans a wide variety of indications as well as treatments meaning faster development for your products. Our scientists are capable of wearing many hats, including, but not limited to, project manager, medical writer, and clinical trial manager.
At Cato Research, all the clinical strategy scientists are involved with medical and regulatory writing. In addition, Cato Research has dedicated medical writers with experience in preparing various different types of documents that have resulted in successful regulatory submissions.
Clinical trials are research studies that test how well new medical approaches work in humans. These biomedical and or behavioral research studies are designed to answer specific questions about new therapeutic products or procedures with the aim of generating safety and efficacy data, data used to support regulatory submissions, and approvals across the globe. Often expensive and complex, these trials represent some of the most significant value enhancements for pharmaceutical and biotech companies. Success relies on good clinical trial design and effective and efficient execution. Delays and failures are costly. They can significantly impede the availability of new and innovative products that may improve life for patients and their families.
Cato Research provides expert clinical trial operations (CTO) services to the pharmaceutical and biotechnology industry. Our CTO staff are skilled in clinical trial management, clinical monitoring, expedited study start-up, patient recruitment, and the execution of study feasibility assessments. Cato Research prides itself in being able to skillfully execute the vital operational best practices needed to ensure that your trial is conducted according to your time, quality, and cost objectives.
Clinical Trial Management
To ensure that your study is executed in the time frame you require and with the quality expected by regulatory agencies, our clinical study managers will partner with you every step of the way. Our study managers will map out operational objectives that are likely to have the most direct and most significant impact on the time, quality, cost, and outcome of your program. Using state-of-the-art best practices, our study managers will lead your dedicated project team and ensure that your trial remains well planned and executed throughout the project life cycle. Key focus areas include efficient study start-up; strategic patient recruitment; high-quality yet efficient trial operations; proper trial operations decision making and documentation; and strong clinical research associate (CRA) leadership and oversight.
Our CRAs are an extension of you. We are sure you will agree that they are positive, professional, thorough, and articulate. Our CRAs are experienced at working effectively with sites to ensure that our patient recruitment and study execution goals are met. CATO clinical monitoring services include traditional, full-service monitoring, as well as risk-based and centralized monitoring services, depending upon your goals and the needs of your project. Both office-based and regional CRAs are available for assignment to your project.
Study start-up is one of the key cost drivers in your program. Experienced decision-making in the areas of study site selection, required essential document collection, and investigator contract negotiations can make or break your timeline. CATO has study start-up specialists, including dedicated contracts and budgets experts, who ensure that your study is started and enrolling as quickly as possible.
We understand the challenges and importance of a successful patient recruitment program. We take a proactive approach to develop a strategic enrollment plan that is patient centric, data driven, and site specific. Our dedicated team builds a strong relationship and nourishes loyalty and trust with the study sites. Combined with a passion for engaging patients as study partners, we empower sites to enroll the appropriate patients in your study in the shortest time possible.
Our feasibility assessment team will collect and summarize valuable, detailed feedback from clinical research sites to support critical decision-making in your clinical development program. We will help determine important parameters such as patient enrollment rate, number of sites needed, local standard of care, viable patient assessments, potential study challenges, and investigator grants. Our goal is to collect the specific site feedback needed to make your study a success. The information our team gathers is summarized in a feasibility report with key recommendations.
Why We Do It Better
Experience, longevity, training
CATO’s CTO group is comprised of CRAs and clinical study managers (CSMs) from around the world who are experienced in all aspects of clinical trial execution. From feasibility assessments to study closeout and all steps in between, our staff members pride themselves not only in doing things right but also in doing the right things. Forty percent of our CTO group have secondary educational degrees with some having achieved medical degrees or Ph.D.'s, education, an attainment that helps us uphold our corporate mission of being the “premier, scientifically and medically based, international healthcare research and development service company.”
Longevity and company loyalty are evident in the average 4 years of continuous employment by most of our CTO staff, with some having more than 10 years' tenure with CATO. On average, CATO CRAs and CSMs have over 12-13 years’ experience in clinical research. Our five-member CTO Leadership Group has approximately 100 years’ combined clinical research experience.
In addition to routine clinical research training sessions, CATO provides its CRAs with annual GCP training and an extensive CRA training program, which includes a mentorship program for new CTO staff members. CATO encourages membership in the Association of Clinical Research Professionals, and many CRAs have achieved and maintained certified CRA status.
Successful development of a health care product relies on accurate and relevant data. How that data are analyzed and represented has a significant impact on the successful progression of that product towards market by satisfying regulatory requirements.
As a global contract research organization (CRO), Cato Research provides over 29 years’ data management experience to ensure your project has the most effective, efficient, and quality system for your trial. In collaboration with you and the entire project team, Cato Research will design the best tool with the options most suitable for your protocol design. Cato Research’s teams are experts in providing unique and flexible options for even the most unique design, both statistically and clinically. Cato Research’s family-friendly culture and positive learning workplace offers benefits that keep employees for the long term. Your data manager is dedicated to your project from start-up to closeout.
Over the last five years, Cato Research has performed data management activities for studies across all phases in the following therapeutic areas: neurology, immunology, hematology, oncology, cardiopulmonary, allergy, cardiovascular, gastroenterology, endocrinology, ophthalmology, dermatology, and others. These studies include animal studies, devices, medical foods, biologics, vaccines, and drugs.
Cato Research’s data management group offers expert data management services that include the following:
Auditing and consulting for all data management activities
Skilled staff dedicated to project teams
Full-service or stand-alone data management services using Cato’s technology partners or your data management system
EDC, paper and hybrid systems and processes
Management of external vendor data including central and local labs, imaging data, ePRO, ECG, biomarkers, PK/PD, etc.
A highly skilled team led by a dynamic manager and supported by the entire senior management team within Cato
EDC training for sites and the project team as well as EDC help desk services.
Our data management teams are trained to work in several EDC systems, including the following:
Cato Research has an experienced data management team dedicated to working collaboratively with the project team in designing and implementing state-of-the-art systems and processes.
Using the protocol, data management will work with the project team to develop the EDC system to meet the needs not only of the sites, but also of the statistical analysis. A detailed data management plan will be developed to highlight data management processes and document all project-specific decisions. This plan will be reviewed by the project team and updated throughout the project as necessary. The data management team will offer training to all users of the EDC system, provide day-to-day support, and manage user accounts.
Throughout the life of the study, data management will review and monitor the data as well as assist the sites and CRAs as they enter and review data. Data management will provide data listings and reports to support the remote monitoring of the data by the CRAs, a step that can potentially reduce the time needed at the sites. The entire team will work together to ensure the database locks on-time or early.
Once forms and their associated edit (validation) checks are created, and assuming that a company adopts and enforces standards, forms and form elements can easily be reused for other studies.
Well-designed and well-executed clinical trials are critical to the successful development of drugs and devices, but just as important is the statistical relevance of the data that supports the conclusions drawn from the trials. Data collected from trials and studies to support regulatory applications and submissions have to meet strict standards for statistical design and analysis. Trials therefore need to be designed and executed to meet these standards.
CATO has many years’ experience in providing statistical work and advice through all stages of the drug approval process, from preclinical analyses up through postmarketing results. Our statistical team works with sponsors to develop and execute statistical analysis plans that cater to each sponsor’s and trial’s specific goals and needs, while also providing advice and guidance regarding how to meet regulatory requirements. We also work closely with data management to ensure that there is a clean, efficient workflow from collection of data through analysis and reporting of results.
CATO is able to provide sponsors with the following services:
Study design and other statistical consulting
Protocol development and review
Sample size and power calculations
Development and production of randomization schemes, schedules, and blinding
Drug supply calculation
Case report form review
Statistical analysis plans
Phase 1 – Phase 4 clinical trials analysis and reporting
Production of tables, listings, and figures
PK and PD analysis and reporting
Adaptive and Sequential trials
Data analyses, summaries, listings, and CRF tabulations that conform to the FDA or other regulatory agency guidelines for submissions
Support for regulatory agency requests and meetings
The goal of Medical Affairs at CATO is to provide high-quality medical oversight and advice to all phases of the drug development process.
CATO physicians have extensive experience with:
Ensuring patient safety, providing superior clinical expertise, and meeting regulatory requirements
Direct patient care, academic medicine, teaching, and all phases of drug development
Medical writing, grant writing, peer review publications, editorial process, journal editing, and authorship of books, monographs, and other documents
Writing and editing of INDs; NDAs; BLAs; orphan status applications; fast track applications; pre-IND packages; EOP1, EOP2, and EOP3 packages; and grant applications to NIH, NCI, American Heart Association, and the Howard Hughes Medical Institute
Professional presentations at meetings of medical congresses, steering committees, investigators, data and safety monitoring boards, and FDA advisory committees
Clinical practice that includes emergency medicine, internal medicine, preventive medicine, oncology, otolaryngology, pathology, pediatrics, cardiology, critical care, clinical pharmacology, genetics, infectious diseases, laboratory medicine, occupational and legal medicine, neonatology, pulmonary diseases, and both animal and human toxicology
CATO's Pharmacovigilance division within Medical Affairs maintains global medical oversight operations, including development and implementation of customized safety processes that routinely undergo quality improvement.
Pharmacovigilance provides all necessary support for safety database construction and maintenance, adverse event reporting, and other standard safety functions, including post-marketing safety and special interest in the design and implementation of electronic CRF and regulatory documents.
Selected clinical trial experience includes: immune globulin and monoclonal antibody therapy; pulmonary hypertension; asthma; chronic obstructive pulmonary disease; respiratory distress syndrome; adult respiratory distress syndrome; congestive heart failure; acute myocardial infarction; stroke (neuroprotection); gene transfer (heart and skeletal muscle); inflammatory bowel disease; osteoarthritis; diabetic neuropathy; cancer (colon, lung, melanoma, stomach, pancreas, leukemia, lymphoma, stem cell therapy); Alzheimer’s disease; schizophrenia; epilepsy; and vaccines (cancer, DTaP, N. meningitidis, HiB, C. jejuni, anthrax, and plague).
Pharmacokinetics is a branch of pharmacology dedicated to the determination of the fate of drug substances administered to a living organism. PK describes the relationship between the processes of drug absorption, distribution, metabolism (biotransformation), and excretion (ADME), to the time course of therapeutic effects or any adverse effects of drugs.
Cato Research offers comprehensive clinical PK consulting services for drugs and biologics, including PK trial design, data analysis, data modeling, and reporting. Our PK experts have the necessary skills and experience in designing clinical PK studies to meet our client’s needs and regulatory agency requirements in the most cost-effective and time-efficient manner. PK study designs may include: single and multiple ascending dose Phase 1 studies, special populations including renal and hepatic impairment studies, food-effect, and drug-drug interaction studies, among others.
CATO also provides these PK services for supporting our client’s nonclinical studies, including non–GLP-compliant PK modeling and reporting as well as GLP-compliant toxicokinetic (TK) modeling and reporting. Our toxicologists can design not only the TK component of nonclinical safety studies, but have extensive experience in designing the entire nonclinical program for the development of drugs and biologics.
The Nonclinical Safety Development group at Cato Research was created in 1998 and has since expanded the company's capabilities in terms of pharmacology, safety pharmacology, ADME, and toxicology expertise and services. Our combination of scientific, technical, and compliance expertise allows us to design nonclinical development programs that meet regulatory agency requirements in the most cost-effective and time-efficient manner without compromising the quality of the overall safety assessment. Our scope of services include the following:
Nonclinical Development Plan
Our toxicologists will author a nonclinical development plan specifically for your product. This is a comprehensive document that fully lays out all the steps needed for a successful IND filing as well as the nonclinical program needed to support clinical development beyond the IND.
If significant nonclinical information is already available, an alternate approach that addresses the needs of some of our clients is a nonclinical gap analysis, which seeks to delineate gaps or deficiencies in a current or partially executed nonclinical program, and offers concrete recommendations for addressing these gaps or deficiencies.
The following are Integral to our nonclinical development plans: estimates of the amount of test article required; estimates of study costs and overall nonclinical program costs; and estimates of the time needed to execute the nonclinical program.
Execution of the Nonclinical Plan: Nonclinical Study Support
Our toxicologists have extensive experience in planning, conducting, and monitoring toxicology studies that have used a broad variety of routes of administration, and in an array of animal models used in pharmaceutical development. Types of nonclinical safety studies include, but are not limited to: ADME; safety pharmacology; single- and repeated-dose toxicology; genotoxicity; carcinogenicity; developmental and reproductive toxicology; immunotoxicity; and neurotoxicity studies. Our study support services typically include the following activities:
Generation of product-specific study outlines to obtain quotes from qualified nonclinical contract research organizations (CROs)
Contacting the CROs to request competitive price quotations, negotiating costs, and setting up details for the contractual agreement between the CRO and our client
Negotiating and implementing study schedules in order to streamline the nonclinical development program, and to achieve our client’s project milestones
Estimating test article requirements
Reviewing and implementing the study protocol to ensure that it fulfills our client’s needs and regulatory requirements
Acting as the main contact for technical and scientific toxicology issues raised during the conduct of the study
Conducting monitoring visits to the selected CRO(s) in order to monitor critical steps of each study and to ensure compliance to study protocol, CRO SOPs, and GLPs
Reviewing audited draft reports and ensuring their finalization in a timely fashion for inclusion into the regulatory submission
Analytical and bioanalytical support for the nonclinical program, including CRO costs and scheduling, method validation studies, and PK/TK analysis and modeling
Getting Your Product into the Clinic: Nonclinical Regulatory Support
Our Nonclinical Safety Development group is highly experienced in meeting and interacting with regulatory agencies, including the FDA (CDER, CBER, and CDRH) and Health Canada. We routinely author the nonclinical sections for the following:
Pre-IND meeting packages (and in the case of cellular and gene therapy products, pre-pre-IND meeting packages)
IND and IDE submissions
Clinical Trial Applications (CTAs)
End-of-phase meeting packages
NDA, BLA, and PMA submissions (eCTD format)
What distinguishes Toxicologists at Cato Research from Others?
Efficiency: our toxicologists will streamline the nonclinical program specifically for your product, and will not simply apply a "check box" approach for study requirements.
Impartial bidding process: our toxicologists will obtain competitive bids from multiple nonclinical CROs.
Team approach: our toxicologists will work closely with the CMC, clinical, and regulatory experts at Cato Research.
Regulatory experience: our toxicologists will transition seamlessly from the planning and execution of the nonclinical program, to presenting and discussing the nonclinical data with the regulatory authorities.
Selection and Management of Vendors
Cato Research works on many different therapeutic technologies and indications. Each project has specific requirements that are often best served using a specific laboratory or service provider. Cato does not have our own laboratories and therefore has complete flexibility in the selection of the best possible capabilities in each case. Over the years, Cato has built relationships with many providers and have come to understand the strengths and weaknesses of each. As a major client of many leading vendors, Cato Research also has leverage in receiving priority attention and competitive pricing on behalf of our clients. CATO has qualified experts that manage all aspects of preclinical development, these experts are supported by the input of regulatory teams who provide guidance on the basic nonclinical needs for any specific regulatory goal.
Integrated regulatory, clinical, and nonclinical expertise are rarely available from one organization. Cato Research offers all according to your needs.
Project management is the discipline that integrates all aspects of a project’s operation to achieve efficient and effective execution from beginning to end.
Cato Research has established a strong framework for successful project management by supporting its clients and their projects with professional, skilled project managers, coupled with the tools and performance metrics necessary to ensure that projects are delivered on time and on budget — regardless of their complexity.
With diverse capabilities and services spanning all aspects of manufacturing, nonclinical and clinical development, regulatory strategies and submissions, covering geographical operations that range from local, through regional to international, crossing all phases of development, Cato Research has experience in integrating and managing extremely complex initiatives and programs with an impressive track record for delivery. We can accommodate clients with program management needs covering all facets of a development pipeline, and can provide project management support for both specific internal resourcing gaps or outsourced projects as they arise. Our project teams work closely with each client and all partners in customizing the project plan to rapidly and flexibly meet the needs and requirements for the client’s program and collaboratively manage risks and develop innovative solutions toward a successful outcome.
Cato Research offers extensive integrated services for investors and the executive management of virtual companies. In these cases, CATO not only provides project management for each aspect of drug development, but also centralized management of the whole program on behalf of the client. This is possible because of the breadth and depth of services available at CATO and the level of expertise of our management and staff.
Introduction of quality processes and procedures early during development saves time and money, facilitating an efficient and successful development program with minimal delays.
Cato Research believes that audits are a vital part of every development program. Experienced auditors conduct on-site visits, perform electronic quality reviews of documents, and train or retrain your personnel, as needed. Our auditors can identify problems and offer advice for timely corrective actions during any phase of the development process, thus avoiding costly delays and other setbacks. We are very flexible and will tailor our services to address your requirements and expectations.
To support your development program, CATO provides several types of audit and compliance services; for each of these, we use FDA or country-specific regulations and International Conference on Harmonisation (ICH) guidelines as the audit standards. Audits we offer include GCP, GLP, GMP, and various QC activities.
Sponsors are required to demonstrate that their clinical trial–related activities are conducted and reported according to the protocol, SOPs, and country-specific GCP regulations and international guidelines (especially ICH E6). A GCP audit is a systematic and independent examination of clinical trial–related activities and documents to determine compliance with GCP expectations. Audits of the Trial Master File ensure the presence of mandated documents at clinical sites and the sponsor site before, during, and at the end of each clinical study.
Nonclinical studies (both preclinical and concurrent with clinical trials) that demonstrate safety during various stages of clinical development often are contracted to commercial or university laboratories. These regulated safety studies are to be performed in compliance with GLP regulations, which ensure the quality and integrity of the safety data, as stipulated in ICH and country-specific guidelines. CATO's GLP auditors are trained to monitor nonclinical study sites before, during, and at the end of nonclinical testing. Our monitoring procedures assure sponsors that safety studies are being conducted appropriately and will withstand regulatory scrutiny.
Investigational products must be manufactured in accordance with GMP and also coded and labeled in a manner that protects the blinding required by the study protocol. In addition, the labeling must comply with applicable regulatory requirements. CATO auditors are trained to detect problems in these areas and to recommend corrective actions. They conduct facility audits, examine documentation for equipment maintenance and vendor qualification, monitor production activities, and perform preapproval preparation inspections.
CATO has experienced quality assurance auditors who perform thorough site audits to ensure all aspects of appropriate regulatory guidance are met. Before the audit, audit team members discuss the purpose of the audit and any specific areas of interest or concern with the sponsor. Our auditors prepare an audit plan or agenda, review study protocols (if appropriate), generate necessary document checklists, send a confirmation letter to the site, and prepare an audit certificate.
During the audit, which may include multiple days on-site, the auditors conduct an introductory meeting to discuss expectations, and a debriefing meeting to discuss findings. While on-site, auditors document all activities performed, discussing the findings and attempts to resolve them during the site visit.
After the audit, the lead auditor signs an audit certificate for inclusion in the site’s files and then generates a follow-up letter to the site and a detailed audit report for the sponsor. The audit report details activities performed during the audit, any findings, and any recommendations regarding corrective and preventive actions.
Quality Control Activities
CATO excels at performing data audits of sponsors’ clinical study reports. After our comparison of tabular data in the draft report to information in source documents (e.g., SAS tables), we compare text to tables, and then synopsis to text. Our review includes confirming reference citations, performing sectional cross-checks, and ensuring that all parts of the report are consistent with the appropriate template.
Clinical protocol QC reviews are performed by CATO teams to ensure that protocols are unambiguous and can be followed uniformly across clinical sites. Our teams consist of editorial content, scientific, clinical, medical, and statistical reviewers whose efforts help ensure the quality of your product. One result of our detail-oriented QC review is to minimize the need for subsequent amendments.
We can also assist you with production of high-quality internal and regulatory submission documents by ensuring QC of data within nonclinical or clinical reports and performance of cross-checks to ensure consistency within and across documents. We are able to perform gap analyses of your SOPs and quality systems to identify missing elements or deficiencies, and can assist with implementation of corrective and preventive actions.
Why We Do It Better
Our commitment to flexibility enables CATO to act and react to changing situations quickly. We will modify the scope of audits and QC activities based on what the sponsor needs. Because most of our quality group has worked together for a long time, we possess the institutional memory that enables us to work together efficiently and well toward achieving common goals: we know how to get things done and are highly motivated.
Sponsors are ultimately responsible for the integrity of the data generated in their clinical trials by their third-party vendors (CROs). This is most evident in recent FDA warning letters issued to top-quality pharmaceutical firms for failure to oversee the activities of their contract research organizations and other vendors. Oversight of clinical trials is commonly performed by the pharmaceutical company sponsor themselves, however, there is a trend towards outsourcing the oversight responsibilities to experienced and independent CROs on behalf of the main sponsor.
Quality oversight is a means of overseeing the activities and assure the quality of work performed by clinical vendors or the sponsor themselves. A third-party quality oversight program provides an unbiased and objective assessment of the CRO’s work effort. It eliminates any inherent bias that may exist in a long-term relationship between a sponsor and its CRO—a bias that makes it difficult for the sponsor to adequately assess the CRO’s performance.
Quality oversight is well-aligned with the FDA’s Clinical Trials Transformation Initiative and, as it is accepted as a critical trial process by a large number of firms, will increase its positive impact. It also is aligned with the FDA’s call for industry to be more innovative in its clinical trial work. However, this initiative stretched beyond North America with global oversight of international clinical trials becoming increasingly commonplace. A trial-specific, formal quality oversight plan could be part of any prospective trial review conducted under the agency’s pilot initiative for adaptive clinical trials.
Cato Research is experienced in performing oversight services on behalf of international pharmaceutical companies for trials that extend across Europe, North America and Latin America. Use of highly experienced monitoring personnel coupled with quality driven assessment protocols ensures that the needs and expectations of both the sponsor and regulators are met and that the trial and data generated met the desired quality standards.
Regulatory affairs is concerned with ensuring that companies, their products, and the process of developing new products, meets international and local regulations and requirements. Continual innovation in healthcare technologies means that regulations are dynamic. Companies seeking regulatory submissions and approvals continually seek the most efficient regulatory path based on the data and evidence available to support their case.
Knowledge of the regulations is not enough. Familiarity with the various regulatory groups and their preferences is essential to achieve the most efficient and successful outcomes. This familiarity comes from frequent interactions with different regulatory sections, including the presentation of challenging and innovative products.
As a global CRO with more than 29 years’ experience, including frequent successful interactions with regulators on a wide variety of products and technologies, Cato Research provides expert regulatory affairs consulting and services, including the following:
Regulatory strategy throughout the life cycle of your product
Regulatory contact capabilities
Regulatory submissions (can support both paper and eCTD)
Regulatory support during clinical trials
Choosing the right regulatory strategy can mean the difference between a relatively quick and pinpointed IND clearance process or a drawn-out, expensive process that typically results in frustration both by the sponsor and regulatory agency. Cato Research has the expertise and track record to design innovative regulatory strategies to ensure an efficient IND clearance process.
Additionally, Cato Research has experienced Ph.D.-, Pharm.D.-, and M.D.-level writers to ensure your regulatory strategy is efficiently translated into documents for ease of FDA review. These documents include:
NDAs and BLAs
Orphan Drug Designation Applications
Fast Track Applications
Request for Designation
Special Protocol Assessments
Effective communication with the FDA allows an effective working relationship for a biotech or pharmaceutical company and is important for clearance of the IND and the eventual approval of the NDA or BLA. CATO offers personalized attention and timely, critical advice related to what questions to ask the FDA and when in addition to what not to ask the FDA and which questions are in the "gray area." Cato Research has broad and deep relationships with many FDA reviewers and project managers and can act as your regulatory contact as the official representative who communicates with the FDA on your behalf.
Why We Do It Better
Cato Research also has extensive experience in regulatory submissions, both in legacy (paper) and eCTD formats, including assisting sponsors with the transition from paper to electronic regulatory submissions. CATO’s electronic submission software utilizes Lorenz/docuBridge, the same software used by the FDA for viewing electronic submissions. Cato Research averages 350 submissions per year and has in-house expertise in the complicated process of formatting and quality checking regulatory documents during the regulatory submission process. Cato Research has never had a refuse-to-file from the FDA.