Working with clinical data in complex and high risk projects in the life sciences industry requires a specialist set of abilities including:
- Systematic Literature Searches & Retrieval - To locate and assemble all relevant clinical and scientific information.
- Critical Appraisal - Of the evidence to ensure it is scientifically robust (internal & external validity) and fit for purpose.
- Detailed statistical analyses and comparative effectiveness reviews.
Using the above skill sets we rework existing evidence and generate new evidence in support of various scientific and commercial applications including:
Re-Working Rejected Files - including new product registrations or pricing submissions that have been rejected by regulatory authorities or that are seeking to mount an appeal.
Overcoming Paucity or non Existing data - including performing systematic reviews and comparative effectiveness reviews in support of regulatory applications where the data is weak and insufficient and new clinical data needs to be generated.
Working with incidence and prevalence data - orphan drug applications that require assembly of this information to build a scientific case and argument.
Generating new clinical data - in support of new product claims or comparisons, extensions to product indications and supporting Industry Code Challenges and Defences including the provision of advice or second opinion on files or the evidence in support of the development of e.g. regulatory, marketing, pricing strategies.