Work With An In-Country Clinical Trial Depot To Increase Efficiency AndMaintain Compliance
By Soudeh F. Tehrani, Lisa Lemelin, and Anh-Thu Le, Project Managers, Clinical Distribution
It is no secret that the road to drug approval is rife with challenges ― it is long,costly, competitive, and the odds are stacked against developers. For a sponsor toget their drug to final approval, they’ll need to identify and leverage resources thatyield time and cost savings while also maintaining compliance, traceability, andquality across drug development and manufacturing processes. Since clinical trialsare becoming increasingly international in scope, some drug sponsors are opting toform partnerships with global contract research organizations (CROs) that canmanage their trials to help them achieve these goals.
Conducting a clinical trial in the right market can be a game-changer, andpartnering with a global CRO is a strategic advantage. Take Canada for instance, apowerhouse in the clinical trial arena. Canada contributes to 4% of clinical trials worldwide, ranks fourth in the number of clinical trialsites, and leads the G7 in clinical trial productivity. Moreover, Canada offers the second-lowest trial management costs among G7countries. If you are considering a clinical trial in Canada, collaborating with an in-country clinical depot can be highly advantageous.This localized clinical material partner consolidates shipments, warehousing, and distribution to one central location, streamlining theentire process.
Common Challenges to Managing International Trials
As the clinical trial market becomes more globalized, the opportunities to partner with global CROs are growing. To work effectively witha CRO based in another country, a drug developer needs to be cognizant of any obstacles that might arise. Consider a few:
Supply chain disruptions have a major impact on the availability of essential raw materials for clinical trials. When importinggoods from other countries, a trial runs the risk of being delayed without critical resources.
Maintaining regulatory compliance across multiple global jurisdictions is complex; it requires continuous communicationwith local authorities and regulatory experts.
Rising clinical trial costs are an ongoing concern across the industry; conducting them globally, however, may increase expensesdue to logistics as well as regulatory and legal fees that can differ from country to country. To avoid going over budget, cost-savingstrategies must be implemented wherever possible.
For these reasons and more, consider the noteworthy benefits of partnering with an in-country depot for your international clinical trial.
The Impact of Working with a Clinical Trial Depot
A clinical depot is a space designed to warehouse and distribute clinical trial necessities, such as highly sensitive raw materials, within thecountry of a clinical trial site. These depots offer several advantages to drug companies, including providing a designated hub to whichlarge quantities of material can be imported. By strategically choosing a depot partner, you ensure your raw materials are readilyaccessible throughout a trial. However, the benefits don’t stop there.
Increase Efficiency and Reduce Costs
In-country partners save time in trial management. Consider a situation where an urgent shipment may be needed at a trial site. Quicklyarranging an international delivery can be challenging due to added paperwork, logistics, and costs. Working with a depot that pre-storesand consolidates shipments to one location helps reduce regulatory paperwork that may impede time or progress. Furthermore, since thedepot is located within the same country as the clinical trial sites, your team avoids costly international shipments and leverages fasterdelivery. In-country depots can ship overnight to ensure most shipments arrive within 24 hours. If you opt to work with a clinical depotthat offers a brokerage service, they will also facilitate customs release procedures for your team and complete the necessarydocumentation for shipping drugs to the country in which the depot is located. Documentation and import/export activities are simplifiedwhen handled by a partner familiar with these procedures.
Additionally, in-country depots offer an audited and reliable facility to warehouse your product locally until it needs to be distributed tohospitals, clinics, and patients. This efficiency is yet another means of controlling bottom-line expenditures, reducing risk, andminimizing supply chain complexity.I. II.
Maintain Consistent Regulatory Compliance
Maintaining regulatory compliance is not always a straightforward process. Due to the highly regulated nature of the pharmaceuticalindustry and the tendency for regulatory requirements to change over time, development teams must be continuously monitoring shiftsand adapting approaches to stay compliant. Opting to work with a clinical depot that is informed and up to date on local regulations canbe highly beneficial for your clinical trial’s compliance. Local regulatory experts will help your team stay abreast of the regulations of thejurisdiction. A depot can also house clinical trial documentation related to any activities they carry out, maintaining traceability andcompliance with health authority regulations throughout their processes.
Reach Patients Faster
Time is a precious resource, especially when it comes to potentially life-saving clinical studies. Each roadblock eliminated from your pathto market aids your drug in reaching patients as quickly as possible while conserving resources. An in-country clinical trial material depotis a wise choice on the fiercely competitive road to drug approval.
References
Government of Canada. (2022, February 9). Government of Canada. Innovation, Science and Economic Development Canada,Office of the Deputy Minister. https://ised-isde.canada.ca/site/canadian-life-science-industries/en/biopharmaceuticals-and-pharmaceuticals/clinical-trials-environment-canada
About the Authors
Soudeh F. Tehrani, Project Manager, Clinical Distribution
With a Ph.D. in pharmaceutical science, she possesses a comprehensive understanding of the drug development process from bench tobedside. She began her career in the pharmaceutical industry as a researcher, focusing on the development of active substances and newformulations for pharmaceutical, orthopedic, and cosmetic applications. Additionally, she has over eight years of experience in preclinicalstudies. In January 2023, she joined the Ropack clinical distribution team as a Project Manager, where she contributes to providing high-quality services for the distribution, storage, and destruction of clinical trial batches.
Lisa Lemelin, Project Manager, Clinical Distribution
Lisa has her Bachelor of Science in Biology and has been involved in the pharmaceutical industry for over 23 years. From starting out at asmall biotech company in drug discovery and sequencing to working in a research lab at the pre-clinical level to managing clinical trialdrugs at one of the world’s top pharmaceutical companies, she has seen all facets of the industry. This has allowed her a betterunderstanding of what is involved in the drug development process. She joined Ropack in 2014 as a Project Manager where she was ableto share her knowledge with the company and help continue to offer excellent services to Ropack’s trusted clients and partners.
Anh-Thu Le, Project Manager, Clinical Distribution
Anh-Thu started her career in the clinical study field as a student while completing her Bachelor of Science degree. In total, she hasworked in the pharmaceutical industry for over 19 years, acquiring experience along the way in a number of areas, from laboratory workto managing the stability programs for various pharmaceutical companies. In 2017, she joined Ropack as a Project Manager, providingquality customer service while also making sure to fulfill client demands.
About Ropack Pharma
Ropack offers manufacturing services such as powder blending, encapsulation, bottle, blister, and sachet packaging. We provide aserialized supply chain that is proficient, verified, and ready to safeguard your pharmaceutical product and the patients who depend on it.We also offer manufacturing and distribution of clinical trial materials across Canada. We ensure that your clinical trial materials arehandled properly from warehousing, distribution, and collection through destruction. Additionally, we process expiry extensionrelabelling requests in our cGMP facility. We also assist our partners with documentation for drug product importation.III. 1.