Comprehensive and customized clinical trial consulting for medical devices.

• Development and/or review of Clinical Study protocol format and content, including input on study design, biostatistical assumptions and analyses;
• Identification of relevant clinical endpoints pertinent to the safety or performance of the device; and
• Review of protocol, informed consent, and Investigator’s brochure for compliance with ISO 14155 Good Clinical Practices for Medical Devices.

• Lead project management activities, ensure review and study oversight for sponsors during the execution of all study phases;
• Identify and select clinical service provider(s) based on the study resourcing needs (full or customized services, third-party vendor(s));
• Qualify clinical service provider(s);
• Establish and maintain Trial Master File (TMF).

• Interactions with Regulatory Authorities (Notified Bodies, National Competent Authorities);
• Preparation and submission of requests for Investigational Testing Authorizations (ITA) with Health Canada or Investigational Device Exemptions (IDE) approvals with FDA;
• Coordination of initial and protocol amendment submissions with local and/or central IRBs/REBs; and
• Registration of investigational studies in national registries (e.g. clintrials.gov).

• Identification and/or selection of Study Sites;
• Site and Study team training;
• Execution and reporting of study monitoring across all study phases (initiation, enrolment, close-out); and
• Support with regulatory authorities’ inspections.

• Audit of clinical study site;
• Audit of clinical procedures;
• Identification and qualification of service suppliers (laboratories, logistics, transportation, etc.); and
• Audit of service suppliers.

• Develop and review study safety reporting plan and forms to ensure compliance with applicable safety reporting regulations for medical devices;
• Support sponsors in receiving, reviewing and processing safety information to ensure timely mandatory reporting as applicable; and
• Submit expedited SAE and/or ADE reports per the requirements of regulatory authority(ies).

Offering a full spectrum of Core Labs with imaging solutions tailored to our clients’ medical device-specific needs.

Through our partnership with Beam Radiology, we provide an end-to-end suite of medical imaging services with timely interpretation, using state-of-the-art instrumentation and technologies, to enhance and expedite medical device development; the whole seamlessly integrated into the workflow of the clinical trial.

Helping you write, execute and maintain quality!

Quality work is directly linked to regulatory compliance. In partnership with LOK North America, we commit to delivering work of the highest quality. Leveraging LOK North America's fully certified MDSAP ISO 13485 quality management system, we diligently supervise each project. This instills a heightened level of confidence in our ability to consistently meet and uphold regulatory standards, ensuring timely completion and effective resource allocation.

Optimize your clinical research strategy.

Through our partnership with LOK North America, we offer a wide range of medical device consulting and regulatory solutions to help our clients navigate the relevant regulatory framework and comply with the Food and Drug Act and the Medical Devices Regulations requirements. We will provide assistance to our client and bring unmatched skill and objectivity to your medical device regulation strategy.

We are committed to assisting our clients and bringing unparalleled expertise to their medical device regulation strategy.