Scientific Affairs

Once your needs have been clearly identified, the Scientific Affairs Department will prepare a study design that will accompany your tender. This team of experienced scientists integrates innovation, expertise and the latest scientific development news in order to provide accurate and up to date results. This team maintains a continuous strong relationship with regulatory agencies around the globe for study design reference purposes. As a result, Clinical Trial Applications (CTA) conform to legislative demands and the projects advance smoothly. They provide adapted Bioavailability/Bioequivalence or other clinical trial reports thoroughly written according to regional guidelines:

• U.S. Food and Drug Administration (FDA)
• Center for Drug Evaluation and Research (CDER)
• Health Products and Food Branch (HPFB)
• Therapeutic Products Directorate (TPD)
• European Medicine Evaluation Agency (EMEA)
• International Conference on Harmonization (ICH)
• Therapeutic Goods Administration (TGA)

The Scientific Affairs team provides study protocols and informed consent forms in both English and French. With their broad range of experience, Algorithme Pharma's team can serve as a reliable reference for both scientific and regulatory issues.

Algorithme Pharma's seasoned scientists can provide data transfers and electronic submissions for both Pre-Clinical and Clinical Evaluation. All documentation is provided in Report Templates (CTD, PCERT or ICH) and electronic Abbreviated New Drug Application.

Further department services include:

• Statistical plan development
• Pharmacokinetic analysis
• SAS code programming
• Integrated study report
• Custom format report
• Pharmacokinetic/Statistical report
• CD-ROM copy and hard copy of the reports along with associated study data PCERT preparation for TPD submission
• Final report submission to authorities