Medical & Scientific Affairs

Veteran physicians. Trial experts.

You can develop your drug candidate with more confidence when you have the benefit of skilled and experienced medical professionals on your team. Our Medical and Scientific Affairs department has knowledgeable and highly qualified physicians with the expertise to support your programs from a medical perspective during pre-clinical and Phase I-IV clinical studies.

PharmaNet/i3 medical professionals are located throughout the US, Europe, and the Asia-Pacific region, and have expertise in a wide range of therapeutic areas including general medicine, oncology, surgery, cardiology, neurology, psychiatry, endocrinology, rheumatology, infectious and metabolic diseases, nephrology, pulmonology and pediatrics.

Our veteran physicians have supported hundreds of clinical studies from the medical perspective and meet client’s specific needs from protocol development to the final clinical study report in a variety of ways:

Clinical Development Planning Product Safety Regulatory Training
Support, prepare and conduct: Assess product and study safety: Support and prepare local regulatory submissions: Provide training on:
Gap Analysis SAEs Marketing Authorization Applications Clinical development planning
Develop and write the clinical development plans Conduct and write annual safety updates New Drug Applications Product specific training
Feasibility studies (assessment of common clinical practice, epidemiology and competitive study activity) Handle interactions with Data Safety Monitoring Board and data listing. Orphan Drug Applications Non-specific therapeutic area
Identify investigators and key opinion leaders Review protocols and assess project risks Pediatric Investigation Plans (Europe) Pediatric regulations

 Provide 24/7 support to investigational sites and project team about issues and questions related to the protocol or eligibility criteria Risk Minimization Action Plan (US)

Write product safety narratives

Phase IIb-III Brochure

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