Strategic Sourcing Meeting, Wokingham, UK

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We have a proven business model, incorporating strategic staffing and clinical management expertise.

We have developed and implemented a strategic sourcing approach over the past nine years that allows sponsors to leverage our clinical research expertise and the depth of our resource pool. Our approach also includes oversight from subject matter experts and senior management, making our model flexible, efficient and cost effective.

Our Experience

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5 We offer five flexible sourcing models that can be adapted to meet your specific needs.

Our strategic staffing and clinical management oversight offers the right balance for companies seeking a proven business model for successful clinical trial services. Our global reach and scalable resourcing models help ensure timely completion of your global trial, which allows you to focus on core product development. This outsourcing—either complete or partial—is customized to your exact needs. In addition, we work to ensure a seamless integration with the sponsor team.

This allows sponsors to focus on their core competencies by shedding the day-to-day responsibility and costs of employee management, and also ensures the services they need are being provided by trained and proficient resources.

Functional Models

1. Outsourcing: Resources at a Premier Research office or regionally to sponsor who provides work delegation and project management. Functional areas: study management, CRAs, study start up managers, clinical contracts, SDTM programming, SAS programming, data management, medical writing, and safety management

2. Insourcing: Resources at sponsor location, to sponsor who provides work delegation, project management, and systems access

3. Offshore Solution: English-speaking experts at our offices in Central and Eastern Europe provide data operations services: data management, database programming, lab data loading, safety management, and clinical programming

4. Hybrid Solution: A mix of outsourcing models are utilized to execute a clinical research function

5. Consulting/Atypical Projects: Requests not met through core operating groups including: quality assurance gap analysis, database hosting, project management consulting, data management report development, remote medical coding, site data entry, database and CTMS administration, TMF maintenance and management, systems validation, and more

Proven Experience

We have experience with the following services:n CRA resourcingn Medical writingn Data managementn Safety management n Statistical programmingn Site contracts/payment administration n Trial master file managementn Lab data handling n Multilingual help desk supportn Database development and administration

Expertise: the Peoplen Teams able to provide additional resources

when, and for as long as, needed to meet all critical timelines

n Subject matter experts that serve as project leaders in all functional areas

n CRA resources with specialized therapeutic experience located near major medical centers