3 Tips for Comparator Sourcing
In the process of learning how to develop drugs, comparator sourcing is important now more than ever. Comparator drugs are used in trials to compare the effectiveness of new drugs with previously available ones. Unlike a placebo, which looks identical to the drug but contains no active ingredients, the comparator is the current market drug being used to treat the target of the trial drug. Pharmaceutical companies face growing problems like competitors testing against their product, as well as the packaging and labelling products to look like a real drug. So here are 3 tips to help overcome these issues.
Plan Ahead to Source Comparators
The problem with sourcing comparators are intensified by the growing complications of the clinical supply chain. It’s best to plan a comparator sourcing strategy before the clinical trial begins, as early planning provides flexibility and opportunities to identify possible risks. In the planning procedure, it’s important to list key details about the clinical study including countries, the number of test subjects, the duration, strength of the comparator, and much more. These are required to accurately predict supply needs and conduct the planning work necessary for reaching optimal solutions.
Distribution, Regulations and Expiry Dates
Some of the chief concerns is around distribution, regulatory approval and expiry dates. Scheduling the supply and distribution of comparator drugs can be difficult, considering the regulatory requirements are different depending on the country. Regulatory authorities look at the quality and manufacturing process of comparators. If they need to be re-packaged and labelled to look like the test drug, this could interfere with regulations like the Falsified Medicines Directive. Comparator drugs usually take the same time as clinical trials to form, which usually takes up to 12 years. This means it’s vital the drugs have sufficient long expiry dates to be approved by regulatory authorities and ensure the safety of patients.
With high expenses in clinical supplies, more vendors are used to solve the problems that sponsor companies have. With multiple involvement in the drug development, there are issues of decision making which causes more delays. If a vendor isn’t given enough time to source comparators, it goes to the open market for competitors to discover. It’s best to choose an experienced partner who’s proficient at international and local souring, regulatory support, and transportation management.
Would you like to find out more tips on comparator sourcing? If you’re looking for a detailed session on comparator sourcing that is relevant to the industry today, your search is over! This October, the Clinical Trial Supply Southeast 2018 conference will address ways to handling a growingly complex supply chain. For more information, please visit http://www.arena-international.com/ctssoutheast/ or alternatively email us at: firstname.lastname@example.org
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