Service Information

Leveraging our unrivalled level of experience in providing access to medicines throughout the entire medicine lifecycle, our Consulting Services provide tailored solutions for pharmaceutical and biotech companies, from early clinical trials through to commercially licensed medicines.

 

Key facts

25+

Biopharmaceutical companies using our Consulting Services

18

corporate access policies/strategies developed

9

communication strategies created

6

of the top 15 pharmaceutical companies supported

Our services are comprised of the following solutions, tailored to the specific environment surrounding your medicines:

Policy Development

Our strategy and policy development service enables pharmaceutical companies to leverage our extensive experience in the early stages of drug development to help create policies, processes and strategies that ensure a clear corporate position on early patient access to medicines (internally and externally). For example:

  • Developing a process to ensure continuity of treatment for patients exiting a clinical trial and consistent access to new patients with unmet medical need across different countries
  • Future-proofing your organization against constant changes in the regulatory and political environment and from changing stakeholder preferences and expectations
  • Complying with latest regulations
Asset Strategy

There are many factors that impact the successful transition of a medicine from the unlicensed to licensed marketplace and a thorough, robust strategy is vital to realise a product’s full potential. For over 30 years, Clinigen has been helping patients gain access to unlicensed medicines across the globe and this has provided us with a unique insight into this environment.

Our Asset Strategy service combines our extensive experience with individual expertise in core marketing disciplines, to provide a comprehensive roadmap for an asset across the following areas:

  • Patient Forecasting > Projected patient numbers for early access programs to assist in client forecasting and modelling
  • Regulatory Landscape > Review of regulatory environment across markets to identify optimal approach to medicine access
  • Operational Footprint > Identification of roadblocks and solutions to enable comprehensive access to client’s Investigational
  • Medicines across global markets
  • Communication Planning > Identification of key opportunities for complaint communications to all relevant stakeholders
Real World Evidence

Capturing Real World Evidence (RWE) is vital for gaining a competitive edge in an environment where adaptive licensing and pricing pressures are becoming ever more prevalent.

RWE as part of a managed access programme (MAP) is the first opportunity to collect data outside the confines of a clinical trial setting, providing valuable information about medicines in the real world population well ahead of launch.

Our RWE offering allows you to capture anonymised data that can help gain unique insights into how patients are diagnosed and treated in a real world setting. Compliant data capture is accompanied by the support of our RWE experts, on hand to answer key questions that allow for better decision making across all functions within your organization. Our technology enables the capture and review of data in real time to support:

  • Commercial and Market Access
  • Health Economics and Outcomes Research
  • Clinical Development and Safety