Scientific Services

Providing scientific partnership from candidate selection through licensing

Profil Institute’s Scientific Services Team is comprised of Ph.D. and M.D. research scientists highly experienced in designing metabolic study protocols and creating documents for regulatory, safety and ethics review authorities throughout the world. They are also key contributors to the clinical development planning process from regulatory filing to final report and publication. Members of the team serve on the editorial boards of several major scientific journals and hail from top research and academic centers including the WHO Collaborating Center of Diabetes at the Heinrich-Heine University of Düsseldorf, National Institutes of Health, Sanford-Burnham Research Institute, and the Salk Institute for Biological Studies.

Profil Institute’s scientific services include:

  • Scientific publications for peer-review journals
  • Oral and poster presentations for national and international industry and scientific conferences
  • Scientific consulting and participation on scientific advisory boards
  • Establishing and managing scientific advisory boards for our clients
  • Study design and protocol writing
  • Clinical study reports
  • Investigator brochures
  • Target product profiles and prophetic package inserts
  • Regulatory documents, including Investigational New Drug (IND) filings and annual IND reports
  • Data and Safety Monitoring Board (DSMB) reports

Internally, Profil Institute’s scientific services team takes a thought leadership role in:

  • Investigator-initiated studies of new metabolic clinical research methodologies
  • Publication of investigator initiated study results in the public domain
  • Contributions to scientific journals and participation at industry conferences
  • Writing and publication of textbooks for diabetes treatments and metabolic clinical research