Clinical Operations

Source: inSeption Group
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inSeption’s Clinical Operations and Project Management subject matter experts are integrated into the client’s project team, thus ensuring a more streamlined approach to providing the required support and/or recommending ways to achieve new efficiencies.

Our Project Management subject matter experts:

  • Are passionate, experienced clinical professionals who have a documented track record of providing quality work and are driven by service; thereby, eliminating costly re-work.
  • Provide end-to-end support and efficient solutions for every stage of the clinical trial lifecycle, including pre-study, startup, maintenance, reporting, and close-out services to support all clinical study needs.
  • Oversee the management of the operational aspects of clinical trials including protocol development, investigator recruitment, patient enrollment, study specific guidelines, processes and quality of data collection.

Our Clinical Scientist subject matter experts:

  • Assist the CEO and CMO with all aspects of the development, planning and strategy for the portfolio of assets (Asset Profile, Target Product Profile generation).
  • Generate clinical development documents, with appropriate matrix team input, to support the development strategy (Product Development Plans, Clinical Development Plans).
  • Develop concept protocols; participate in design, writing, and implementation to meet ICH GxP standards.
  • Develop and design studies to determine the scientific and clinical viability of products and interpret the results of these studies by providing expert impute.

Site Management and Clinical Monitoring

Our experienced Regional Site Managers (RSMs) are recapturing the importance of building relationships with clinical sites. Our RSMs can act as a “one-stop shop” for all activities related to a clinical study site.

Our Site Management and Clinical Monitoring subject matter experts:

  • Act as a primary point-of-contact with investigational site personal to build relationships and ensure efficient conduct of study activities.
  • Responsible for all aspects of clinical monitoring from start-up activities (feasibility, regulatory document collection, initiation) through routine site monitoring and management to close out activities.

Our solutions include:

  • Full Service Outsourcing
  • Functional Departmental “Carve-Outs”
  • Functional Service Provider (FSP) Outsourcing
  • Individual Consulting/Direct Hire