Expertise
Montrium offers know-how in specialised areas through its team of expert consultants. Please see below their profiles by categories.
GCP Auditors
Montrium GCP Auditors are highly qualified multilingual professionals (English, French, German, Spanish, Italian) with a broad knowledge of drug/device development process, ICH GCP guidelines, Health Canada, FDA and EMEA regulations and other applicable regulations. Our auditors have a minimum BSc or MSc in life sciences including pharmaceutical sciences. They have all between 8 and 18 years experience in drug development, CQA, clinical research, regulatory compliance, and clinical study monitoring or equivalent. They can build a full clinical study audit program and conduct a broad range of audits including investigator sites, vendors, study processes, regulatory submission documents, software development and validation (CSV), TMF, clinical CROs, and central labs as needed. Our Auditors can also provide or coordinate GCP training with clients. Auditors can prepare, format, and/or review Standard Operating Procedures (SOP) as needed. Montrium has the team, the experience and the skills to conduct independent due diligence audits of a clinical development programme during the acquisition process of new medicinal products. Montrium GCP Auditors conducted more than 600 compliance audits in various therapeutic areas in North and South America, Europe and Asia.
GLP Auditors
Montrium GLP Auditors are highly multilingual professionals with a broad knowledge of drug/device development process, OECD GLP guidelines, Health Canada, FDA and EMEA regulations and other applicable regulations. Our auditors have a minimum BSc or MSc in life sciences including pharmaceutical sciences. They have all between 18 and 23 years experience in drug development, GLP QA, bioanalytical project management or equivalent. They can build a full pre-clinical study audit program and conduct a broad range of audits including GLP facility audit, study protocol audits, animal study audits, raw data audits, bioanalytical audits, software development and validation (CSV) and central labs as needed. Our Auditors can also provide or coordinate GLP training sessions with clients. Auditors can develop, format, and/or review GLP Standard Operating Procedures (SOP) as needed. Montrium has the team, the experience and the skills to conduct independent due diligence of pre-clinical studies during the acquisition process of new medicinal products.
Regulatory Specialists
Montrium Regulatory Specialists are highly multilingual professionals with a broad knowledge of drug and biologicals development process, Health Canada, FDA and EMEA regulations and other applicable regulations. Our Regulatory Specialists have a minimum MSc or PhD in life sciences including pharmaceutical sciences and pharmacology. They work with Sponsors at all stages of development offering regulatory intelligence consulting and regulatory submission development (CTA, IND). They can assist clients with the preparation of key drug development documents such as Study Protocol, Investigator’s Brochure, Clinical Study Report, CMC section, CTD modules, etc.
Statisticians
Montrium Statisticians are highly bilingual professionals with a broad knowledge of statistical design for clinical research. Our Statisticians have a MSc in Statistics and have more than 20 years of experience. They work with Sponsors at all stages of clinical development offering services such as study design, sample size calculation, development of statistical analysis plans, analysis of clinical data and ad-hoc consulting. They can also assist clients with training sessions in statistics.
