Three crucial factors to consider when sourcing comparator drugs for clinical trials
Originally appeared on the CSM website. View original
From early stage biotech to the biggest of global pharma, every sponsor organization is different, and every clinical trial presents unique challenges sourcing, packaging and distributing clinical trial materials. Having the right comparator drug supplier provides maximum flexibility and options, and the ability to better identify risks. But how do you choose the right one?
THREE CRUCIAL FACTORS
Clinical supplies professionals regularly find themselves juggling responsibilities and wearing many hats. They must manage both their clinical colleagues and their vendors, and find themselves short on time while being challenged to deliver products faster than ever and drive down trial cost.
In many therapeutic areas products are increasingly expensive and patients hard to recruit. Striking a balance between continuous supply and excessive overage is essential, as is protecting the supply chain from falsified or counterfeit drugs and ensuring safe and timely delivery to sites and patients.
These are the three key factors that we believe are needed in a comparator drug sourcing partner to help overcome those challenges and deliver outstanding results in an increasingly complex and competitive trial landscape:
It is common for a modern clinical trial to be spread over four or more continents. Knowing which products are registered, launched and available in different territories during trial planning is crucial to avoiding problems downstream. The right provider has a global comparator network and can provide timely and accurate assessments of what products are needed, where they are available, how much they cost and how long they take to source. They can also provide guidance on how often to source and label, and where to store and distribute materials.
Established relationships with branded and generic manufacturers
Access to high-value branded products may be restricted by their innovator, and lower value generics can be plagued by shortages. It is fundamental to work with a vendor who has a strong track record and long term relationships with manufacturers and distributors. The right provider can help educate stakeholders on the challenges of commercial drug sourcing, ensure that expectations are aligned and robust processes are in place across the supply chain, and even add value in ways you might not have considered.
Experience that allows agility
Working with an experienced partner is crucial. No matter how well-prepared you are, the unexpected can happen. Recruitment forecasts can be wildly inaccurate, new sites or countries can be added, and regulations can change which can have a major effect on cost-effectiveness. The more experience you have assisting you in designing and executing supply chain and regulatory strategy, the better.
REDUCE WASTE, OVERAGE AND OVERALL COST
With its unique global footprint, truly strategic approach and established relationships, CSM, a Clinigen Company, is able to maneuver around product changes, drug shortages and logistical hurdles. As a single provider, it can supply not only comparators, but innovative packaging, labeling and distribution services through CSM. It also offers compassionate use and unlicensed medicine solutions, and can act as a commercialization partner.
Partnering with CSM dramatically reduces the waste, overage and overall cost associated with comparators whilst proving you with the absolute piece of mind of working with the market leader. In the last five years, we have delivered medicine to over 130 countries.
Visit the CSM website here