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