Providing Consulting and Contract Services Globally.
What We Do
Clinical Research
Our team is continually keeping up with the changing clinical research trends and technology. We strive to find the most efficient ways to conduct and manage clinical trials (Phases I-IV) both internally and at a site level.
Regulatory Affairs
Our team will be your partner in making safe and effective healthcare products available in Canada, by providing exceptional service in defining Health Canada requirements, preparation of submissions (CTA and NDS), for a wide range of products, including: pharmaceuticals, biologics, blood and cell products, medical devices, nutritional products, supplements and cosmetics.
Medical Affairs
We partner with your commercial team in providing scientific and clinical support for pre and post launch stage. This includes managing key thought leader relationships, working with data and publishing reports from clinical trials, working on research initiatives outside of labelled indications, presenting educational information, providing product safety information for healthcare professionals (e.g., physicians, pharmacists, nurses) and to patients.
In addition we can work with business units in management of phase 4 trials, design and development of registries, conduct of pharmacoeconomic trials and assistance of investigators in conduction of investigator initiated trials from inception to publication.
List of Services Provided
Clinical Research Services
- Development and writing of Protocols, Informed consent forms, Investigator's brochure, Monitoring plans, Project management plans, Initiation and pre-study visit guidelines.
- Development and update of SOPs for clinical research department
- Project management of clinical trials phases I-IV, including registries and ISTs globally.
- Preparation and submission of IRB/REB applications for sites.
- Monitoring of local sites and resolution of issues and data collection.
- Collection and review of regulatory site documents for sites globally.
- Training of site staff in protocol implementation.
Regulatory Affairs Services
- Project management of regulatory submissions across programs involving one to several countries globally.
- Preparation and submission of clinical and CMC applications as per Health Canada guidelines.
- Dossier compilation, publication, communication with agency and overall management.
- Preparation and submisison of DIN, NPN, CTA, CTA-A, CTA-N, NHP and Medical device applications.
- Product monographs and labeling, Establishment license, Administrative applications.
- Regulatory interpretation of Health Canada guidelines and development of strategies.
- Submission of CTA applications on behalf of Investigators/Researchers.
- Dossier review and gap analysis .
Medical Affairs Services
- Development of e-learning materials and training modules for MSLs.
- Development of presentations and scientific briefing documents for payers (private or public sector).
- Development of patient information materials.
- Training of physicians and health care providers in GCPs, management of clinical trials, development of ISTs/IRTs, collection and presentation of data, submission to IRB/REBs on behalf of investigators.
- Preparation and submission of CTA application(s) on behalf of investigators to Health Canada.
- Phase IV and registry design for government affairs and marketing, program management, IRB communication, data collection and successful implementation.
- SOP development to guide operational aspects and compliance for Medical Affairs.