Real World Evidence (RWE) is increasingly recognized as an invaluable research tool that provides a robust and cost effective core element to any product development plan. Life sciences companies are embracing new strategies, partnerships, and technologies and with them the application of RWE methodology throughout the development lifecycle.As a result, they can realize fresh opportunities to discover, optimize, and demonstrate value even during traditional early phase research. TCRS’ expertise in RWE covers the following areas;
RWE strategy and planning
Our expertise can help guide your strategy and develop the most cost effect path towards your product approval and reimbursement across global markets. Defining patient populations and outcome measures requires close collaboration with hospitals, providers and patient advocacy groups. Our experience has shown this to be the most efficient way to define optimal inclusion/exclusion criteria and gain patient buy-in – critical if a study is to be delivered rapidly and with minimal protocol amendments.
Non-interventional (NIS) / Observational / Patient Registry studies
Our expertise in delivering non-interventional or observational type research studies will provide you with a robust data set through cost-effective methodology. Often these studies are delivered using the ‘traditional’ Phase II/III clinical research management paradigm. This mindset inevitably means that you end up with large research teams, processes that are over-engineered for the task and a large cost estimate to deliver the study. TCRS understands that keeping the study as simple as possible and making sure it is easy for both site and patient to take part are key to achieving a successful outcome.
Post-Approval Safety Studies (PASS)
There is an increasing trend for regulatory authorities to allow products onto the market with the caveat of a mandated Post-Approval Safety Study (PASS). These studies have specific approval, design and reporting parameters that must be adhered to. However, proactively conducting a voluntary PASS study can avoid some of the more rigid requirements that a regulator might impose. As a result the voluntary PASS is becoming an important part of risk management plans.
Patient Preference Studies
Sometimes referred to as Patient Centered Outcomes Research, these studies provide insight into the overall benefit of a new product. They achieve this by investigating how to optimize overall outcomes while also addressing the burden to individual patients, healthcare providers and payers. This methodology enables the early identification of potential barriers to uptake of a new product. TCRS can provide guidance in developing the optimal path for your product before you embark on your first steps on the development ladder.
Natural History Studies
The clinical research environment is constantly changing. Potential therapeutic agents are increasingly complex, personalized medicine is changing the way we manage clinical development and there is a growing need to target ever more niche or rare diseases to gain rapid product approvals. This means that the need to fully understand the target disease area and patient population has never been greater. An extremely cost effective method of gaining a clear understanding of disease area, patient population and even currently available therapies is to run a relatively short observational-style study before embarking on early phase research. These studies can have many names (including NIS and Observational) but a “natural history study” is becoming the most commonly used way of describing this up-front research.