The Power of RTSM Problem Solvers on your Team - You spend an enormous amount of time assessing technology vendors through RFIs, pilots and capability presentations. Not only must the technology fit your needs, but you also make a judgement call based on the trust and value of the future relationship. Ultimately, the decision may weigh in favor of someone you can envision your team working well together.
We’ve been seeing a lot of messaging around agility in Randomization and Trial Supply Management (RTSM) or as some refer to it, Interactive Response Technology (IRT). Is “agile” becoming the new “innovative”? Does everyone understand what it truly means to be agile with regards to software development? What about project delivery? Both are equally important, but we can argue that agile software enables agile project delivery and not the other way around (which has its limitations).
Clinical News Roundup for the week of May 29, 2017 with information on cancer patients finding their own trials, Marken launching a new hybrid clinical trial service, a call for clinical trial overhaul, and Califf making a new start with Verily.
Conducting clinical trials for rare, debilitating diseases can be particularly challenging, owing to the smaller patient population with limited mobility and greater caregiving requirements. Direct-to-patient shipping of clinical trial drugs, while not typical, might help to reach these patient populations who otherwise would struggle to participate in and comply with clinical trials. However, implementation of this strategy is challenging because of many reasons such as the logistical considerations and regulatory requirements regarding patient confidentiality and quality control. Recently, Bioclinica collaborated with a sponsor to successfully ship study drugs directly to patients.
Marken collected a shipment from southern Sweden that was bound for next-day delivery in northern Belgium. However, all airline flights into Belgium were cancelled as a result of a strike action by airport workers.
Based in Fargo North Dakota, CSM is a full service packaging and labeling company that specializes in supplying investigational medicines, including cancer drugs and supplies for clinical trials.
The pre-qualified Certis GPS-RP pallet shipper is designed specifically for loading a standard 48” x 40” pallet into the designated payload space.
Life sciences organizations face more pressure than ever to run efficient, uninterrupted manufacturing production at the lowest possible cost. To stay compliant with government regulations, quality and manufacturing organizations must precisely follow Good Manufacturing Practices (GMP) standardized processes and maintain an associated document control process that adheres to those requirements.
The CryoPort Express® Standard Dry Vapor Shipper is lightweight and re-usable combining the best features of packaging, cryogenics and high-vacuum technology.
The Cryoport Express® Combo Liquid Nitrogen Dry Vapor Shipper uses a dry vapor liquid nitrogen (LN2) technology to maintain below -150° C temperatures with a dynamic shipping endurance of 10+ days.
Today, there is more focus than ever on temperature monitoring. With increased fragility of biologics and increased scrutiny on maintaining temperature budgets, it is critical that frozen shippers not only maintain their temperature budgets but also have the data to prove it.
Today biotechnology and pharmaceutical companies operate on a global scale. Research labs and manufacturing sites are often on multiple continents, and development partnerships and product distribution span the globe. But with that global reach come the difficulties of getting temperature sensitive biological materials to the right place safely. Whether it’s clinical specimens that are collected in East Asia and tested by a CRO in the U.S., or such bio-pharmaceutical products as vaccines that are sent to distribution channels in Asia or South America, the biological product being shipped is of high value and temperature sensitive.
