1. Stakeholders In Clinical Research The Pharma Company Professor Phil Warner

2. What Does Pharma Expect From Clinical Research?

3. What Does Pharma Expect? It is a customer Therefore requires a service to meet its needs It wants to evaluate its drug as efficiently as possible It needs ethical research conducted according to the law/guidelines Through all trials stages;

4. What Does Pharma Expect? It expects an all the skills and other resources required to be present It expects the required documentation etc. to be in place It needs to trust the clinical researcher- It remains responsible! It wants to pay a fair price! It wants the data as quickly as possible

5. What Does Pharma Expect? Investigators Patients/participants Sites A team that works and with whom it can communicate The right expertise Data it can trust Data outputs it can understand

6. How are Pharma’s Needs Met Well here are a couple of views on how they do it

7. Solutions that set your products apart For every bio pharma company, it’s the ultimate goal—differentiated drugs that deliver demonstrable patient benefits, that physicians recommend and prescribe, and whose cost/benefit profiles payers endorse.

8. Our expertise in developing and delivering commercial solutions, working alongside those in clinical development, means we can: better identify, promote and prove the value of a particular drug to key stakeholders discover new efficiencies accelerate positive outcomes reduce unnecessary complexity

9. In a marketplace where the demands of customers, payers and patients are constantly changing, Quintiles has a broad range of commercial solutions and the agility to help you successfully differentiate your products across their lifecycle to relevant worldwide

10. Start up time is critical to the success of a clinical trial as delays translate directly into lost revenue. Sponsors benefit from experienced sites and efficient management of trials. PharmaSeek’s ability to quickly identify high-performing sites for Sponsors allows a clinical trial to begin without delay.

11. We evaluate the history of a site and the background of its investigative staff before proposing it as an option to the Sponsor or CRO. Our facilitation of rapid site activation saves time and reduces costs.

12. Once we become involved in a project, we assign a project manager as a single point of contact for the Sponsor, CRO, and investigative sites. The project manager facilitates efficient communication, allowing PharmaSeek to keep the clinical trial moving forward at all times. Additional value to Sponsors and CROs accrue from the use of one contract template and budget for multiple sites

13. PharmaSeek does not have exclusive relationships with our investigative sites. Unlike a broker that charges fees before the work begins, we only receive compensation if the site successfully enrolls subjects into the study. As such, our financial interests are completely aligned with the Sponsor and CRO.

14. Not all Providers to Pharma are Commercial Many investigators work in other organisations e.g. Hospitals and Universities Many of these are now very well set to deal with the pharma industry Here’s how one UK NHS Trust does it.

15. The R&D Office has prepared the following guidance on the process for agreeing Clinical Trial Agreements and obtaining R&D approval for commercial trials in order to assist the Sponsor/CRO and investigator: As early as possible, the commercial organisation should contact the R&D Office.

16. The R&D Office arranges (and if necessary negotiates) the Clinical Trial Contract. The R&D Office requests commercial organisations to use a model Clinical Trial Agreement that has been approved by the NHS and the Association for British Pharmaceutical Industry.

17. The Pharma Company Stakeholder position is quite simple They are a customer of clinical research services Many types of relationship; complete or part of the service Exclusive/preferred partner/non-exclusive But at the end of the day the customer remains responsible - a key difference