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Phase III Clinical Trial Management and Execution

 
INDUSTRY
Pharmaceuticals
SERVICES
Regulatory
Medical Oversight
CRO Interaction
FDA/EMA
Clinical Development
SKILLS
Therapy Area Expertise
Localization
Pharmaceutical Expertise
Six experienced clinical trial physicians provided.
The Challenge

Our client, a mid-sized Swiss pharmaceutical organization, was acquired by a global pharmaceutical company. As part of the acquisition, the parent company planned to ramp up clinical trials with the company’s primary asset. These clinical trials would focus on a therapeutic area of vast unmet need. At the time, the asset was in phases I and II, and being trialled for various indications. However, it needed to undergo further clinical development.

The Solution

Oxford supported our client over three and a half years, helping them find seven pharmaceutical physicians to manage, oversee, and handle the day-to-day operations regarding this therapeutic area covering five global clinical studies.

Over a five-year period, we supplied a head expert with 30 years of experience in the therapeutic area. She had vast experience in setting up and managing teams for complicated phase II and III clinical trials in the US and EU, including pediatric studies. In addition, we connected the client with six experienced clinical trial physicians to manage day-to-day monitoring and paperwork of phase II and III trials.

The Result

Oxford supported the client to source seven MD contract physicians. Our client has now hired the Physician Lead as a permanent member of staff following a successful 18-month contract through Oxford. We helped the Physician Lead develop a team of dedicated, capable, and experienced pharma physicians to support the global development strategy and execution of their phase II and III trials.

Our consultants have been extended for another year and Oxford will continue to support this client towards their end goal point. Due to our dedicated support, the acquisition was completed smoothly and the phase II clinical trials were successful.