Info & Opinion
April 19, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Not all that long ago, shippers of drug supplies for clinical trials were content to know: Did our drug ship? Then they wanted to learn: Did our supplies get stuck in Ukrainian customs—or at the depot? Now Almac Clinical Services is offering another level of detail, allowing sponsors to hop online to learn How long did DHL shipment #4b327EL9-2J56 exceed 26 degrees Celsius during today's trucking strike in Paris?
Almac says its supply specialists believe their proprietary new technology will help clients slice a day (or even three) out of cold-chain quarantines that frequently bottle up biotechnology-related clinical trials. Global marketing manager Jonathan Calderwood notes that quarantine delays are all too routine, especially when supplies must be sent back to a depot.
So the company decided to design a web-based system to accelerate the process. A growing number of temperature-sensitive shipments are monitored during transit, and Almac's system automates the determination of whether those shipments are usable. The goal is to block bad, soured shipments while fluidly allowing fresh, viable ones to be dispensed to patients as planned. "You're taking three days, possibly more, out of the supply chain bottleneck," Calderwood says. "You're looking at a lot more control and accountability."
Real Time Monitoring
Almac uses a third party gadget that includes a thermometer, the ability to record temperatures over time, and a USB port. One of each of the James Bond-worthy gizmos (made by Elpro Technologies) gets sealed inside each shipment.
When the box arrives at a research site, personnel find the Elpro gadget and insert it into a computer. The computer reads the data and learns how warm or cold the shipment was during transit. The site staffers then visit a website for Almac's proprietary Stems system, which helps sponsors monitor the location and status of individual drug shipments and gives the site a printable PDF indicating what should be done next.
While much of the Stems system is automated, there is plenty of flexibility for human managers to be notified by email and make adjustments to the plan as needed. "Decision makers can say, yes, proceed or no, there is a problem," Calderwood says.
The system's continuous tracking should enable sponsors with recurring problems on a supply route to quickly resolve the issues. The goal is to lose less drug during the shipping process, and monitor cold chain shipping issues by the minute if necessary. In a context of stratospheric costs to manufacture small lots of biotechnology supplies, Almac believes the savings from its system could be significant.
The supply chain market in clinical trials, Almac estimates, is growing at a rate of 10-15 percent annually. But demand for ancillary services requiring more expertise may be accelerating even faster.
For their part, Almac's cold chain specialists are always evaluating the performance of competing couriers, the time needed for alternate routes to the same destination. The company has its own warehouses, special containers and other tools that keep it on the cutting edge of the logistics scene in the biotechnology industry. Almac can analyze patterns in cold chain routes by site, study and geography. Perhaps 25 people at the firm are senior advisors on such issues. "We are willing to embrace technology and the web and mobile communications," says Calderwood.
The thermometer gizmo for Stems is so cheap that it need not be returned to the sponsor, eliminating a chore for the sites; it's a single use device. Training is minimal. The system is 21 CFR Part 11 compliant, with a full audit trail of everything that occurs during the shipping process. The website works with any browser, not just those from Microsoft. And the options and logic in the setup of alarms can be complex, allowing interested observers with the right privileges to receive alerts by email when a shipment reaches its destination or has exceeded permitted parameters.
Almac's clients include the largest firms in the industry and, at the other end of the spectrum, tiny "virtual" sponsors. Big companies may have in-house specialists and very narrow needs for Almac to meet. Small sponsors could need more hand-holding and complete clin ops outsourcing options. "They may have no infrastructure at all," says Calderwood.
In general, Calderwood says, the economic downturn may not have dented the industry-sponsored research world yet. But it has intensified the attention on operational excellence for trials that do proceed. "Everybody needs to manage clin ops better," he says. "We need to get the time down. We need to get the costs under control."