Clinical Supply Availability & Speed to Study Start-Up
March 25, 2020|
By Rudy Grant, Clinical Trial Supply Consultant
If you’re part of a clinical study team racing a new product to commercialization, you likely live by these two simple rules: time is money, and the first one to market wins. But just because it’s simple doesn’t mean it’s easy.
That ticking clock is background noise to the responsibilities of regulations, study protocols, supply chains, and patient recruitment — all the details that must be worked out before a study can even begin. The pressure is always there. The longer it takes for a study to start, the longer it takes to complete. The longer it takes to complete, the more time there is for patents to expire, patients to walk away, and competitors to beat you to market (and to the revenue). Getting a study started as quickly as possible is usually a company’s biggest milestone, and rightfully so.
Study operations teams often scramble to bring in the first patient and meet aggressive timelines. Once the study protocol is finalized, tough logistical questions often arise that threaten to derail those timelines. The sponsor drug is typically ready and waiting, but what about the comparators and supportive medications? How quickly can they be obtained and labeled? How quickly can they be shipped to study sites? How long will it take for quality releases to be obtained? Almost inevitably, it’s at this point in the process that costly delays occur.
When the supply chain operations team is tasked with sticking to a timeline, they are hamstrung by the often-lengthy lead times needed to get comparator and supportive medications sourced, labeled, and shipped to study sites. Management doesn’t want to hear that it’s going to take six to nine months; that’s much too long. It’s up to the supply chain team to work some magic and beat that ticking clock. But how?
Mercalis (formerly TrialCard) has an easy solution, and we’re going to tell you about it. But first let’s review the lead times that typically hound supply chain operations, whether they employ CMOs (contract manufacturer organizations) or handle things in-house.
Challenge #1: Sourcing Comparator/Supportive Meds to be Received by the CMO
Steps to success:
- Assign a team (internal and external) to scour the open market for what is needed
- Obtain information on availability and get quotes
- Approve quotes
- Issue prepayment to the source
- Procure documentation for country-related filing and internal records)
- Lead time: two to 24 weeks (drug lead times vary, so this may take as long as four to six months)
Challenge #2: Label Design/Creation
Steps to success:
- Completed in-house or by a partnered CMO
- Starts with an English Label Text that requires regulatory review
- May require translations that must be reviewed and certified by the Quality team
- Produce a label proof for the CMO or printer
- Print the labels
- Lead time: four to 12 weeks (the ordering of the actual label requires two to eight weeks alone, depending on the type of label used)
Challenge #3: Putting the Labels on the Products
Steps to success:
- Operations vary based on suite availability, resources, holidays, the number of shifts currently in operation, and the priority of scheduling
- Ensure operations have both the drug and the printed labels
- Lead time: two to eight weeks
Challenge #4: Batch Record and Quality Review
Steps to success:
- Can only start once the labeling operations are complete (if working with a CMO, a post-review may be added)
- Manufacturer/sponsor must conduct a quality review and release
- Find and resolve any problems or deviations
- Complete a system release within the Enterprise Resource Planning (ERP) or Interactive Response Technology (IRT)
- Lead time: one to three weeks
Challenge #5: Shipment to Sites
- Lead time: usually less than a week
In summary, the total lead time needed to source and deliver medications to study sites can take between eight weeks to nine months! This is an incredibly long time to wait, and the wide variation in times makes it difficult to plan effectively.
How can Mercalis (formerly TrialCard) help your supply chain operations team achieve the same goal in five weeks or less, with a timeline you can count on?
Mercalis (formerly TrialCard) has an innovative but simple solution that will radically change the way you and your supply chain operations team prepare for clinical studies. It’s called the RxStudy Card™. Trusted by some of the top pharmaceutical/biotech companies in the country, the RxStudy Card™ reduces your study lead times from as long as 36 weeks to five weeks or less. Don’t believe it? Here’s how…
Working as a partner during the protocol design stage, Mercalis (formerly TrialCard) suggests risk mitigation strategies and provides program estimates supported by real-world prescription data. Mercalis (formerly TrialCard) then creates a customized RxStudy Card™ program based on the formulary of medications and supplies defined by the protocol. RxStudy Cards are then shipped directly to sites, where they are distributed to patients. Patients use the RxStudy Card™ at their own pharmacy to receive the required medication and supplies. This process takes approximately one month from start to finish, freeing the supply team from sourcing, labeling, and shipping medication and supplies.
No longer is the supply chain team asked to work magic in order to meet startup deadlines; the magic is right there in the RxStudy Card™. It’s a cost-effective, time-saving solution that helps you meet your company’s biggest milestone: speedy study startup that beats the clock—and the competition!
Rudy Grant, Clinical Trial Supply Consultant
Download the RxStudy Card™ brochure for more information.