Extended Encounter

THE CLINTREX ENCOUNTER

The CLINTREX encounter is an interaction between members of a biotech or pharma company and CLINTREX team members. This typically includes internationally recognized experts in regulatory affairs, the disease of interest, preclinical studies, design and execution of clinical trials, and biostatistics.

The meeting is designed to provide a personalized and specific approach to the regulatory pathway, specific regulatory issues, the development program, the need for additional pre-clinical studies, an ongoing or planned clinical trial, or other specific problem.

Each encounter is associated with a specific deliverable, typically in the form of a regulatory pathway outline, a development plan, or a protocol synopsis. The CLINTREX encounter commonly includes:

• An initial teleconference between the company and CLINTREX to learn about the company, its product, goals, challenges, and the immediate problem.
• Transfer to Clintrex of a summary of relevant scientific, clinical, and regulatory materials plus a list of specific questions
• A pre-meeting review by CLINTREX of materials provided by the company
• A full-day meeting with the Clintrex team.  The meeting can be designed to address some or all of the topics listed below:
  • Therapeutic landscape, unmet needs, potential competitors, position in the marketplace
  • Regulatory strategies — approaches to FDA meetings, potential indications, product filing issues
  • Specific regulatory pathway
  • Overall drug development plan
  • Preclinical studies that guide human trial design
  • Toxicology studies
  • Pharmacokinetic studies
  • Clinical trial issues (e.g. clinical population, outcome measures, site selection, site activation, recruitment)
  • Biostatistical issues (e.g. analytic methodology, sample size)
  • Company-specific problems
• Post-meeting deliverables
  • Report summarizing issues reviewed during the meeting and specific recommendations for moving forward
  • Specific agreed-upon deliverable ((e.g. regulatory strategy outline, drug development plan, protocol synopsis)
• Post-meeting teleconference to review and discuss deliverables