It's a notoriously slow process to get the regulatory sign-offs needed to begin human clinical trials in North America, and sometimes developers opt to take their studies to overseas sites where studies can get started quickly. In the interest of speeding trial start-up periods, the McGill University Health Center has joined forces with the tech firm eVision to create software that automates the process of deploying a clinical trial.
In Canada, the process of getting all the compliance paperwork and government approvals in order to get rolling with tests of a medical product in humans can take 8 months on average, Adil Hamdouna, executive director of the Quebec City-based tech firm eVision, told The Montreal Gazette. The process-automation software on which the company and McGill collaborated cuts that time down by 40%.
Time costs lots of money in the biopharma business, and shaving months off clinical development program can save a company millions of dollars. There are a variety of reasons why drug developers conduct trials overseas, including gaining access to patients who qualify for certain trials and costs of doing studies in emerging markets. Yet the long process of meeting all the complex compliance requirements in Canada has benefited countries such as Brazil and India that have streamlined processes, Hamdouna told the Gazette.
"If you can get your ethics (compliance) quickly, then the pharmaceutical firms will give you the contract," he said in an interview with the newspaper.
In fact, eVision isn't the only software company that smells a business opportunity in streamlining trial start-ups. San Francisco-based upstart goBalto has developed an online software product that enables medical products developers to manage manage budgets, contracts and regulatory documents to get trials started. Cmed Technology and others have their own software products to speed trial setups.
- read The Gazette's article