Stratum
INTERNATIONAL PHARMACEUTICAL
CONSULTANTS, LLC
(203) 514-0898 (USA)

©2012 International Pharmaceutical Consultants, LLC

 

 

 

 

Welcome to
International Pharmaceutical Consultants

 

A consulting company focused on the medical and safety aspects of pharmaceutical development.

 

During the past two decades, I.P.C. has consulted on the medical, efficacy, and safety aspects of the development of new pharmaceuticals.

 

Assignments have been with large and small United States and International pharmaceutical companies in a vaiety of therapeutic areas, working as the medical consultant on domestic, international, and global development projects.

 

 

 

 

About


IPC has worked in the pharmaceutical industry for many decades. We have had different types of assignments, e.g., working on one aspect of a program which required developing a single protocol to being the medical consultant for an entire development program, from the first dose in man to regulatory approval.

 

Standard Operating Procedures

Written SOPs for specific clinical research activities and SOPs for an entire program.

 

Clinical Efficacy
Protocols and clinical study reports for all phases of clinical research.

 

Safety
Evaluation of all aspects of safety during clinical development.






Capabilities

  • Standard Operating Procedures for clinical research
  • Pharmaceutical development plans
  • Design and development of clinical protocols for all Phases of pharmaceutical development and special protocols such as thorough qTC studies
  • Medical and safety monitor for clinical studies
  • Being a Member of Data Safety Monitoring Boards
  • MedDRA coding of adverse events and WHOdd coding of medications
  • Writing of safety narratives
  • Medical evaluation of Case Report Forms
  • Review of the clinical database prior to locking
  • Writing and editing of Clinical Study Reports, Periodic Safety Update Reports (PSUR), Development Safety Update Report (DSUR), Investigator’s Brochures, Clinical Sections of the IND and NDA, and IND and NDA Annual Reports

 

Contact

Contact Information

International Pharmaceutical Consultants, LLC
20 Scuppo Road
Woodbury, CT 06798

USA

Phone: (203) 514-0898
Fax: (800) 429-2309

Email: [email protected]