Our expert services include any or all of the following:

• Designing and writing Standard Operating Procedures for clinical research

• Formulating pharmaceutical development programs and plans

• Writing or reviewing the medical sections of the IND

• Writing clinical protocols for all Phases (I, II, III, and IV) of pharmaceutical development

• Reviewing statistical analysis plans

• Generating and/or reviewing safety analysis plans

• Acting as the medical and/or safety monitor for clinical studies

• Coding of adverse events, procedures, medical histories, and concomitant medications

• Evaluating Case Report Forms prior to data entry

• Reviewing efficacy and safety data listings after data entry and prior to generation of the statistical output

• Writing and editing Study Reports for completed clinical studies

• Reviewing and editing study reports written by the company

• Designing, writing, and/or editing the medical sections (e.g., Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS) of the NDA

• Writing the initial Package Insert for an NDA

• Revising or updating Package Inserts for marketed products

• Writing and/or editing of PSUR, IND, and NDA Annual Reports