Disclaimer: This is a user generated content submitted by a member of the WriteUpCafe Community. The views and writings here reflect that of the author and not of WriteUpCafe. If you have any complaints regarding this post kindly report it to us.

Is your organization starting clinical research and looking for a way to conduct it in a safe, timely, and cost-effective manner? Is the program designed to meet regulatory requirements for the multiple jurisdictions where you plan to request market authorization? Consider conducting your early clinical development in Canada. Many biotechnology and pharmaceutical companies have moved their initial clinical research to Canada to get earlier access to first-in-human data, high-quality clinical research, and reliable study participants. Plus, it can help keep costs down. Here are some of the advantages your organization can expect when moving your early phase clinical research to Canada.

Start First-In-Human Trials Earlier

Access to FIH trials in Canada is slightly different than in America. You can start FIH clinical trials before obtaining Investigational New Drug approval. That means your contract research organization can conduct study participant recruitment and screening at the same time as the Clinical Trial Application. This follows Institutional Review Board Approval. With a 21-day timeline, the CTA process itself is also streamlined. Overlapping activities and shorter timelines present an opportunity for significantly earlier access to FIH trial data. You can then use that data to strategically enhance your IND submission in the U.S.

Tax Credits and Favorable Exchange Rates

Another major benefit of conducting early clinical development in Canada is cost savings. If your company already has a presence in Canada, attractive tax credits can contribute to your development program’s cost-effectiveness. A lower currency value, thanks to favorable exchange rates, is another cost-saving factor. Canadian research operates at the same level as the United States’ technology, and the country has comparable scientific advancement. As a result, your organization gets to benefit from these similarities.

Quality of Clinical Research

Canada complies with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, and many reputable clinical research teams call Canada home. These teams are experienced in managing complex studies that span international borders. Plus, they have health research networks and strong information-management systems to support their efforts.

High-Quality Potential Participants

Your clinical trials will have high-quality potential participants, thanks to publicly funded free universal healthcare. The Government of Canada supports the Medicare initiative, which is universally administered while each province is individually managed. There is a “continuum of care” across the country, helping manage patient health and making recruiting for clinical trials more efficient. Pharmaceutical and biotechnology companies can leverage the high quality of potential trial participants during pivotal early phase clinical trials.

Easier Access to Clinical Teams

Canadian contract research organizations offer U.S.-based clients relative proximity, meaning live interactions with staff and program monitoring are possible. Same-day travel to Phase 1 clinical trial units is also possible, and in many cases, travel documents or visas are not required. This can facilitate smooth program deployment and interactions between your organization and the CRO.

About Altasciences

As a mid-sized contract research organization, Altasciences understands all the intricacies of the complex drug development process. This CRO with pharmaceutical CDMO capabilities uses their proprietary communication database to quickly share data across teams, helping streamline your drug development program. Biotechnology and pharmaceutical organizations rely on Altasciences’ integrated, innovative approach for preclinical studies, clinical trials, and manufacturing. When partnering with Altasciences, you gain the team’s expertise in various therapeutic indications and study types. These include first-in-human clinical trials and CNS clinical trials. This dynamic CRO/CDMO offers partners access to a wealth of resources, including Phase 1 clinical trial units with more than 580 beds, a recruiting database of more than 400,000 potential participants, and trained and experienced staff.

Partner with Altasciences for early clinical development in the US and Canada at https://www.altasciences.com/

Original Source: https://bit.ly/3SNa7an

Do you like Altasciences's articles? Follow on social!


Welcome to WriteUpCafe Community

Join our community to engage with fellow bloggers and increase the visibility of your blog.
Join WriteUpCafe