Pharmatech Services to Study Sponsors
Business/Network Development

• Pharmatech establishes networks of physicians in different specialties to run clinical trials, disseminate educational information, and provide training. Sponsors have access to a strong network of investigators to which they can bring a high-quality study without having to worry about site selection/recruitment and management.

Protocol Development

• Medical writers are on staff with the knowledge to generate protocols based on a sponsor’s study requirements and concepts.

Designing of Case Report Forms

• CRFs are standardized and as simplified as possible, making them easier to complete in a timely and accurate fashion. Pharmatech designs CRFs to be comprehensive forms to ensure the capture of all data needed to generate results and outcomes.

Consulting

• Based on many years of research experience, Pharmatech advises sponsors as to feasibility of studies, protocol changes, budgetary requirements, etc.

Regulatory Submission

• Pharmatech can make FDA submissions after studies are completed.
• Protocols and informed consents are submitted by Pharmatech for Institutional Review Board (IRB) approval.
• Pharmatech makes the submission for IRB approval for the vast majority of the investigators in our Network (local IRB situations being the exceptions) that use a central IRB. In most cases, the central IRBs have the investigators on file prior to submittal. This helps to expedite study start-up, potentially shortening the length of time to market for the sponsors’ products.

Project Management

• Pharmatech guides the project from beginning to end, with regard to site selection, timelines, enrollment support, inquiries about protocols, data collection and quality control, grant management, etc.

Data Management

• The Pharmatech Data Management Team enters, tracks, and extracts data from the Case Report Forms as needed, as well as analyzes the data to generate final reports.