Researching rare and ultra-rare diseases sometimes means taking the study to the patients, setting up sites in countries unaccustomed to hosting clinical research. Premier Research will examines the challenges of conducting trials in such unconventional locales in this webinar.
Opening sites in countries where trials are uncommon and not thoroughly regulated requires that sponsors really understand the host country and conduct thorough training in protocol and good clinical practices. Alison Sampson, Senior Project Director, and Hanna Wide, Project Manager, cover these and other topics during Rare Disease Research: Conducting Clinical Trials Where the Patients Are.
Watch today to learn the importance of qualifying patients before opening study sites, and how careful monitoring and oversight will minimize protocol deviations and ensure data integrity. Other topics will include:
- How complex import/export rules can affect your study, such as by restricting sample shipments.
- Travel restrictions that can complicate and compromise your study. For example, if your study takes place in a country off limits to FDA inspectors, your data and documentation must be first rate or the agency might not accept it.
- Widely differing national regulations and processes for site and patient reimbursement that must comply with GCP and the sponsor’s local regulations.
About Premier Research
Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 84 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.