CLINTREX Services

• • Review the therapeutic landscape, unmet needs, and market position
  • Aid in the creation of the development pathway
  • Assist in selecting the clinical operations team
  • Support and augment clinical trial services as deemed necessary and appropriate

Utilize our disease-specific expertise and personal knowledge of investigators and sites to assist in the design and execution of clinical trials aimed at minimizing variability and increasing accuracy (see the section on the Smart Clinical Trials approach for details)

• • Study Protocol - ensure the optimal study design, compliance with regulatory requirements, entry criteria, outcome measures, analytic methodologies
  • Site and Investigators – ensure the correct investigators are selected
  • Investigator Training – ensure knowledge and consistency in the application of the study protocol
  • Enrollment Committee – ensure that the candidate patients not only meet entry criteria but are suitable for the trial
  • Database Management, Statistical Analysis Plan, and Report Generation – can provide or assist in design and oversight
  • Provide oversight of traditional CROs where appropriate or requested
    • Advise with respect to drug supply and study operations
  • Data Safety and Monitoring Boards (DSMB)
    • Establishment of DSMB - Write charter, train members, manage the process
  • Clinical Trials (SmartClinical Trials Method) 
    • The Design and execution of clinical trials designed to minimize variability and increase accuracy (see the section on the Smart Clinical Trials approach for details) Study Design

• • Provide regulatory strategy and guidance
  • Review briefing packages
  • Assist in addressing and resolving clinical holds
  • Provide regulatory advice on issues that emerge during trials
  • Participate in regulatory meetings (including pre-IND, end of phase 2, Special Protocol Assessment (SPA), pre-NDA meetings, and general Type C meetings)
  • Assist in responding to Refuse to File (RTF) and Complete Response Letters (CRLs)
  • Participate in mock advisory committee meetings

• • Protocols and informed consents
  • Clinical study reports
  • NDA clinical documents (ISE, ISS)
  • Advise and assist in publication strategy and writing of manuscripts

• • Perform due diligence and assist in evaluation of new products
  • Provide disease-specific and marketing information to venture capital and other potential funding sources
  • Assist with partnering discussions and leverage our contacts with big pharma/ biotech companies to create partnering, financing, or investment opportunities

• • Act as Chief Medical Officer for companies and provide clinical development, medical affairs and regulatory affairs leadership across all phases of development
  • Act as member of the Executive Team and participate in board meetings and calls with investors or potential partners