Viacure's Clinical Experience

By: Viacure  09-12-2011
Keywords: Project Management, management services, investigators

Clinical Trial Management Services

In clinical trial research, success can depend on the time it takes to bring a product to market.

By combining expertise, innovative ideas and a flexible, responsive approach, Viacure can partner productively with the client to achieve their goal - successful completion of the clinical trial.

Project Management
Viacure offers a comprehensive range of management services for Phase I to Phase IV clinical trials, as well as device studies, and is experienced in remote data entry studies/eCRFS and datafax.

Vital to successful project management is flexibility. Given that each project varies in size and complexity, Viacure provides a customized approach to each client that meets their specific requirements, timelines and budgets.

Viacure ensures each client receives highly personalized and responsive service through open communication between all members of the research team.

Site Qualification
Viacure boasts a national network of experienced Investigators, who have proven track records and are experts in their respective therapeutic fields. Viacure is able to identify and recruit Investigators from their database to ensure each study protocol is partnered with the Investigator's expertise and resources.

Feasibility assessments are forwarded to each Investigator to determine whether a proposed site has the facilities, the staff and the interest to successfully collaborate with the client.

The Investigator is then personally contacted to assess and confirm if the site is capable of meeting all protocol and regulatory requirements. By following such a process, Viacure plays a vital role in developing and nurturing relationships with clinical investigative sites.

Regulatory Review
Along with an in-depth knowledge of current Canadian and American regulatory requirements, Viacure has developed a process for collecting and processing site-specific regulatory documentation that dramatically decreases the time to initiate first investigational product shipment to the site.

Viacure relies on its regional CRAs to assist with regulatory document package collection and review, as they are the most experienced with the local ethics and institutional requirements in their respective regions.

Before forwarding the complete package to the client, to initiate investigational product shipment, the assigned Project Manager conducts a final and thorough review of the regulatory document package to ensure all essential documents are accurate and complete.

Project Coordination & Tracking
Viacure can assist throughout the entire clinical trial cycle, providing individualized service for each client's specific needs. This includes customizing regulatory document status, initiation/monitoring visit schedules, screening/enrollment information and query tracking reports.

Clients can also take advantage of Viacure's real-time project tracking system to keep up to date on their projects on a daily basis.

Clinical Monitoring & Site Management
Viacure provides total site management for the entire duration of a project, from initiation to study close-out.

All members of Viacure's team work together to ensure:

  • Study staff is trained and well-informed
  • Scientific accuracy of the data collected through the source data verification process and logistical checks
  • The clinical trial is in compliance with the current Canadian, American, ICH, GCP guidelines
  • The rights and well being of the human study participants are protected at all times

By utilizing regional teams, Viacure saves the client time and money.

In addition to therapeutic experience and location, CRAs are selected based on the unique requirements of each project. The CRAs are responsible for study conduct and providing ongoing communication, support and follow-up to our investigative sites for the length of the clinical trial. Highly responsive to the needs of their assigned sites, the CRAs are supported by Viacure's Project Managers, who consult with the client to provide timely, consistent and accurate responses to our Investigators.

During the initiation visit, the CRA trains all site staff and continues to provide ongoing support throughout the trial to database lock and study close-out. Viacure views this training as a dynamic process, with members of the team learning from each other to build on existing skills, as well as develop new ones.

Quality Assurance/Auditing
Critical to the ultimate success of any clinical trial is strict adherence to ethical conduct and that SOPs are followed. To ensure this, Viacure's professional staff will conduct independent Quality Assurance audits according to TPD, ICH and FDA regulations.

Viacure's experienced QA auditors make sure that the data submitted is accurate, consistent, concise and adheres to all applicable regulations. Auditors review reports and conduct monitoring visits to ensure the protocol is implemented with the highest scientific rigor between all participating investigative sites. Through this method, Viacure's team is encouraged to provide Investigators with constant feedback to ensure consistency in protocol implementation and reporting.

Upon completion of each project, a performance review is conducted with clients and feedback is given to the regional teams. These teams are evaluated on an ongoing basis for accurate report writing and monitoring efficiency (#queries/visit/CRF ratio).

Keywords: Clinical Trial, Clinical Trial Management, Clinical Trials, investigators, management services, Project Management, Regulatory Document, Trial Management,