708-228-6662 matt@csgbio.com

Services we provide

Medical Writing

  • Protocol and synopsis
  • Informed consent document
  • Investigator Brochure
  • Clinical Study Report
  • Manuscripts for publication
  • Regulatory documentation filing (IND, NDA etc.)

Literature Review

  • Develop subject matter expertise for Client
  • Identify areas of unmet medical need
  • Leverage experience and scientific knowledge gained from review to provide relevant information for guiding selection of lead compounds
  • Enable a data-driven understanding of current status of lead compounds in therapeutics and potential future clinical use (s)
  • Review clinical practice guidelines and treatment landscapes for therapeutic area and lead compound of interest to support clinical development plan

Formulation Support

  • Provide formulation support for clinical study protocol
  • Provide input into and review CMC section of clinical study protocol, investigator brochure
  • Develop investigational product specific study documents e.g. pharmacy manual and ancillary documents
  • Provide input into design of analytical assessments such as compatibility studies, stability studies etc. to support IND

Regulatory Strategy Support

  • Research public domain to help clients stay current on competitor pipeline information
  • Provide summary of clinical trial design and data for related drug products
  • Review and summarize summary basis of approvals (SBA) for related drug products

Advisory board planning and management

  • Partner with Client to identify key opinion leaders (KOL), recruit and maintain relationship
  • Prepare slide deck and deliver presentation
  • Organize and manage advisory board meeting to deliver scientifically rigorous protocol and/or drug development plan

Clinical Trial Operations Scientific Support

  • Provide clinical science expertise to clinical operations group and cross-functional teams
  • Train clinical site personnel (investigator, study coordinators), CROs on therapeutic area, compound and clinical study protocol
  • Serve as scientific resource for addressing or resolving issues during clinical study conduct

Contract Staffing

  • Provide flexible short and long-term contract staffing solutions to meet client project deliverables
  • Partner with client to deliver qualified candidates