Real World Data for Small and Medium Size Companies: they can turn the disadvantage to a winning position.

Many small and medium size companies are disadvantaged because of their limited us of Real World Evidence (RWE) compared to large companies. They don’t need to.

RWE is now being used far beyond its original domains of pharmacovigilance and outcomes research. It is being utilised during the whole life cycles of medicines and vaccines.

Large pharmaceutical companies have multiple departments to generate RWE; including Epidemiology, Health Economics and Outcomes Research (HEOR), Risk Management, etc. They employ tens, sometimes hundreds of staff to work in these areas. RW studies are improving the efficiency of clinical development and enhancing the evidence base for products.

The role of RWE in pharmacovigilance, phrmacoeconomics and outcomes research are well recognised. However, addition RWE adds value in a wide range other areas. An example is that RW studies are now accepted by regulatory authorities not only for marketing authorisation applications for orphan and rare indications, but also as supporting evidence for a large number applications. RW studies are the cornerstone for early access to medicines applications.

There is every reason to expect that the contribution of RWE to pharmacotherpeutics will continue to expand.

Small and medium size companies lose if they don’t benefit from generating RWE. They are deterred by the huge expenses of setting up departments for generating RWE. Howeer, they do not need to establish these. They can get all benefits by engaging external independent RWE experts. In ti way, SMEs can get the benefits at a fraction of the cost. The engagements can be done on a product by product basis or by developing an ongoing relationship for their whole portfolio. This will not only fill the gap, but can put SMEs at an advantageous position. Many of the external experts are more experienced than some of the staff who work on RWE in large pharmaceutical companies. The independent experts works in partnership with the company’s staff and sometimes with other external consultants as a team.

Outsourcing the generation of Real World Evidence by small and medium size companies can turn the disadvantage of SMEs to a winning position at a relatively small cost.

Best wishes
Saad