Pharmaceutical and Biotechnology Services

Protocol design, and writing.
Statistical Plan Writing
Statistical Analysis Full Service Offering
Medical / Scientific due diligence on potential in-licensing opportunities
Inclusion / Exclusion advice for real world enrollment solutions.
Clinical Monitoring, End points, safety evaluations.
Pharmaceutical/Pharmacokinetic analysis.
Preparation of Clinical Study Reports.
Regulatory support services.
IND updates.
Investigator Brochures.
Whitepaper authoring
Website development / content management
Social media management
Manuscripts, posters, abstracts, study reference manuals for multi-center trials
Investigator grant budgeting..
Recruitment strategies that work. Provide on time enrollment without the frustration of delayed or under enrollment for your trial. Difficult to enroll programs made simpler.
Business development services for sites that produce significant increase in revenues. From naïve site development through established site advancement, we are the right partner.
Medical Monitoring, DSMB attendance or formation, signal detection. Safety reporting.
CRO and Site selection advising.
SOP development. QA services. Audit preparations for sponsors and FDA Inspections.
Site selection and training
IM planning services
Data and Safety Monitoring Board (DSMB) Services