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
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 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
