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

  • 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

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
  • Serve as scientific resource for addressing or resolving issues
    during clinical study conduct

Contract Staffing and
Direct Hire

  • Provide flexible short and long-term contract staffing solutions
    to meet client project deliverables
  • Provide direct hire/executive search services
  • Partner with client to deliver qualified candidates