CCS Associates: Redefining Drug Development with RWD

What does your client onboarding process look like?

We are a consulting firm in every sense of the term, and our clients come to us seeking our expertise and guidance in pharmaceutical and device discovery and development. Most of our clients know what they want to achieve. We work to understand their vision and help them gain a perspective on all the pros and cons related to achieving it. Speaking of conducting trials, our understanding of all trials from phase-I to phase-IV is extremely thorough. We help clients understand how therapies need to be tested in any particular phase, the challenges of a trial from a regulatory perspective, and the assessment of the results produced by a specific design model. We further advise clients on reducing the number of patients or expanding the number of sites for the clinical trials to ensure that accrual goals and data acquisition is completed within a set timeframe. We inform the collected trial results with RWD and information to produce a more meaningful result.

Our collaborative approach extends beyond scientific support to include the regulatory side as well to help clients attain approvals for their projects. For this purpose, we utilize our eCTD system to electronically transfer information to regulatory agencies, on behalf of our clients, based on the Common Technical Document (CTD) format. We can do everything from administrative and prescribing information, CTD summaries, quality, nonclinical study reports, and clinical study reports. This system proves to be extremely advantageous to clients as it acts as the single authoritative regulatory archive. It creates opportunities for streamlined interactions with agency reviewers and decreases the response time to agency requests, which results in faster approvals. We customize the clinical data management system to best fit the clients’ needs and use products with proven performance. We utilize open-source datasets in providing design and decision support, and we have a library group that leverages a variety of reference and big datasets to support the research we conduct on our customers’ behalf.

What are the upcoming plans for the future?

With the current COVID-19 global health crisis, we are seeing more clinical trials and studies being based on RWD. Scientists and medical product developers worldwide are utilizing RWD to inform antibody testing, and discover a vaccine. This is precisely the direction towards which we see ourselves moving. We are continuously integrating RWD into the clinical trials process to provide more precise insights into identifying problems and how to resolve them. We are also growing by leaps and bounds by leveraging big datasets and integrating those into clinical trial processes, results, and designs, while also incorporating AI and NLP to improve trial design and product quality outcome. With our association with the National Biomedical Imaging Archive (NBIA), we can easily harness large sets of imaging biomarkers to offer the real world data needed during clinical trials. We will continue to hone our expertise and efficiently integrate IoT and other innovative technologies into data collection, to mine broader sources of RWD and support new models of clinical trials and investigations into the future.