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About Clinical Scientist Group

CSG is an innovative clinical sciences services firm that provides niche clinical development support. Our organization serves as your firm’s quintessential scientific resource, subject matter expert and project manager for your clinical development programs. Our team consists of MDs, PharmDs, PhD scientists with diverse and extensive experience in the pharmaceutical industry. We deliver in-house quality professional services to our client to enhance the quality of the clinical data and patient safety. We provide the following services Medical writing: Protocol synopsis and Protocol; Informed consent; Investigator Brochure; Clinical Study Report; Regulatory documentation filing (IND, NDA etc.) Manuscript for Publication Formulation support: Provide formulation support for clinical study protocol; review and provide input for the CMC section of clinical study protocol; develop investigational product specific study documents e.g. pharmacy manual and ancillary document; provide input into design of analytical assessments such as compatibility studies, stability studies etc. to support IND Data Management: CRF design and streamlining; Data entry completion guidelines; Edit check specifications; Data cleaning and medical review Literature Review: Develop subject matter expertise for Client; leverage experience and scientific knowledge gained from review to provide information for guiding selection of lead compounds; enable data-driven understanding of current status of lead compounds in therapeutics and potential future clinical uses (s); review clinical practice guidelines for therapeutic area to support clinical development plan; 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 Contract Staffing

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