We are ready to support you.

We know there are issues arising from the COVID-19 pandemic that may affect your clinical trial and cause delays. CATO SMS is here to support you! We can assist in the design, refinement, or modification of development plans, accelerate clinical trial preparations, and develop insightful regulatory approval strategies. We can further use cutting-edge, proven technologies to mitigate disruptions at investigator sites and maintain clinical trial momentum.

In order to keep pace, CATO SMS – a CRO with proven performance in complex research areas – (immuno-) oncology, orphan diseases, cell/gene therapy, and advanced therapeutics – can support you in all aspects of therapeutics development during these unprecedented times:

protocol review

Free protocol review

We offer a free and confidential comprehensive review of your protocol synopsis and provide you with strategic and clinical recommendations. We provide input on the design, methodology, objectives, eligibility criteria, background, rationale and practical organization of your study, considering the unique properties of your compound, the competition, and the medical need it will serve
 
feasibility

Free high-level feasibility

We provide a high-level feasibility study by a detailed search in our proprietary databases and initial suggestions from experienced patient inclusion directors and feasibility teams
 
consulting

Free consulting call

We put you in contact with our Drug Development experts whose expertise spans numerous therapeutic areas including but not limited to (immuno-) oncology, CNS, pediatric and adult orphan diseases cell/gene therapies and other advanced therapeutics
 
IND/CTA enabling activities

IND/CTA enabling activities

We provide the full range of regulatory and medical writing support services to develop, write, and submit all aspects (e.g. development plans, chemistry and manufacturing, clinical protocol, investigators brochure) for IND and CTA submissions
 
Regulatory strategy and agency interactions

Regulatory strategy and agency interactions

We develop insightful regulatory strategies to outline your product development pathway, and support in the preparation of and holding INTERACT, pre-IND meetings (US) as well as scientific advice meetings with European authorities, incl. EMA or national competent authorities (CAs)
 
Enabling technologies

Enabling technologies

We provide cutting-edge technology solutions that can help address remote patient consent, in-home patient visits and remote source document review
 


Contact our Business Development teams in North America or Europe now to see how we can collaborate from strategy to approval.

At CATO SMS, our number one priority is the safety and well-being of trial participants, employees, and sponsors, and we recognize our responsibility to the communities in which we live and work. We send our best wishes to you and your loved ones during this difficult time.