Stakeholders In Clinical Research

The Pharma Company

Professor Phil Warner

What Does Pharma Expect

From Clinical Research?

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;

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

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

How are Pharma’s Needs Met

• Well here are a couple of views on how they do it

• 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.

• 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

• 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

• 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.

• 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.

• 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

• 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.

Not all Providers to Pharma areCommercial

• 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.

• 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.

• 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.

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