As crucial to innovation as they are, clinical studies come with a unique set of logistical challenges that can leave sponsors scratching their heads in confusion if they are not properly equipped to handle the situation.
 
For instance, larger clinical studies often require a depot supply of the investigational drug, and possibly comparators, stored at the proper temperature(s) awaiting labeling, kitting, and packaging according to the unique requirements of each study, and able to be shipped to clinical sites, which may have a limited storage capacity, on a just-in-time basis. If any of these conditions are not met, the quality of an expensive and time-consuming study may be significantly affected. 
 
Furthermore, if, as anticipated, clinical studies soon involve personalized gene therapies, there will be an even greater need for just-in-time custom labeling, kitting, and packaging targeted to specific study patients.
 
“Cold storage facilities are expensive to build and maintain and require skilled personnel both for facilities operation and maintenance, and for regulatory compliance,” explains Tim J. Mitchell, President/CEO of Sentry BioPharma Services. For example, Sentry’s facility is equipped with state-of-the-art redundant refrigeration equipment, security, building management/temperature monitoring, inventory management, and backup power systems for storage of temperature sensitive investigational products.
 
“Add to this the need to label, kit and package temperature sensitive investigational products according to strict Time-Out-of-Temperature limits, needing to ship precise quantities just-in-time to various clinical sites both domestic and foreign to meet tight study schedules, and all the while doing so with timely and transparent communications to clients and clinical sites. It becomes a demanding and complex process with significant hurdles,” Mitchell says.
 
These factors are why many companies engage Sentry for assistance with clinical study services.
 
Sentry’s Offerings
 
Sentry offers a full range of storage environments including refrigerated, frozen (-20°C, -40°C, -80°C and custom temperatures between -20 to -90°C), cryogenic temperatures at <-135°C, as well as controlled room temperature (+20 to +25°C) with controlled humidity. 
 
Sentry also offers labeling, kitting, and packaging services, with particular expertise for labeling of frozen materials in controlled Time-Out-of-Temperature, provides distribution/transportation services through qualified vendors for fast, reliable, transportation to clinical sites around the world, has expertise regarding shippers for frozen products, and can provide the latest in electronic tracking and environmental monitoring technology during shipment.
 
“Sentry’s custom labeling, kitting, and packaging services for clinical studies allow its clients to meet critical regulatory requirements to maintain product quality, traceability, and documentation for temperature sensitive investigational products,” comments Alex Mitchell, Sentry’s Director of Operations. “This is accomplished while eliminating any possible negative effect on study quality and doing so in a manner complying with strict study timelines.”
 
According to Mitchell, Sentry provides custom labeling, kitting, and packaging services meeting its clients study-specific requirements which may range from needs for blinded labeling according to randomization sequences to booklet labels which may include specific study instructions.
 
Solving Problems for Clients
 
“Sentry’s clients for our clinical studies services must have reliability, quality, attentiveness, responsiveness, prompt individual attention, meticulous attention to detail, and maintenance of product quality in order to meet the logistical requirements of clinical studies. Typically, this all takes place under extreme time pressure,” remarks John Warner, Sentry’s Executive Vice President. “Sentry takes great pride in using its experience and capabilities to be a problem solver, not a problem creator, for its clients.”
 
The company uses innovative label substrates and adhesives, allowing labeling of extremely cold product and meeting strict Time-Out-of-Temperature limits. Sentry also utilizes innovative technology such as the latest phase-transition shipping containers, and sophisticated electronic tracking and monitoring devices during shipping.
 
“For the most challenging of shipment lanes, Sentry uses advanced technology which pushes real time telemetry of critical data to Sentry’s IT system,” Warner says. “If a triggering event occurs, Sentry key personnel are alerted immediately via email and cell phone text wherever they may be located around the globe.”
 
Sentry’s clients for clinical studies services may engage Sentry at any stage of development for services as needed. However, Warner emphasizes that Sentry is often able to provide even greater assistance regarding study logistics if it is engaged at very early stages of clinical study planning.
 
For further information contact Alex Mitchell at BD@sentrybps.com or 1-317-856-5889.

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