Real World Evidence

Innovative approaches that add value.

Image of a man and women leaning over a laptop talking

Overview

Real World Evidence (RWE) is recognised as an invaluable research tool that provides a robust and cost-effective core element to any product development plan. Applying RWE methodology throughout the development of your clinical lifecycle can give you access to new strategies, partnerships, and technologies.

At TCR-Solutions we offer real world evidence guidance that can help you realise fresh opportunities to discover, optimise, and demonstrate value even during traditional early phase research.

RWE Strategy and Planning

We can help guide your strategy and develop the most cost-effective path towards product approval and reimbursement across global markets. Our unrivalled in-hospital expertise allows us to collaborate closely with hospitals, providers and patient advocacy groups to define patient populations and outcome measures. Our experience has shown this to be the most efficient way to define optimal inclusion/exclusion criteria and gain patient buy-in – critical to delivering a study 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. We understand that keeping the study as simple as possible and making sure it is easy for both site and patient to take part, is key to achieving a successful outcome.

Close up image of a hand hovering over a laptop keyboard

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 must adhere to specific approval, design and reporting parameters. However, proactively conducting a voluntary PASS study can avoid some of the more rigid requirements that a regulator might impose. We can help you conduct a voluntary PASS as an important part of your risk management plans.

Image from behind of a man conducting research on a laptop

Patient Preference Studies

We can provide guidance in developing the optimal path for your product before you embark on your first steps on the development ladder. By carrying out Patient Centred Outcomes Research, we can provide insight into the overall benefit of your new product through early identification of potential barriers to its uptake. The research centres on investigating how to optimise overall outcomes and addressing the burden to individual patients, healthcare providers and payers.

Natural History Studies

The clinical research environment is constantly changing. Potential therapeutic agents are increasingly complex, personalised 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. The need to fully understand the target disease area and patient population has never been greater.

Our expert team can help you carry out the relevant upfront research by running a relatively short observational-style study before embarking on early phase research. This type of Natural History Study (sometimes referred to as an NIS or Observational study) is an extremely cost-effective method of gaining a clear understanding of a disease area, patient population and even currently available therapies.