The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.
To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design. The goal is to be able to respond appropriately to any surprises or issues that could not only jeopardize your study but also potentially delay your product’s development and launch.
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.
This case study details how Sherpa Clinical Packaging partnered with South Bay Therapeutics to craft the best clinical supply management strategies for their multiple, complex clinical trials.
Sherpa’s packaging, storage, and distribution services are built with the customer in mind. As the Sherpas of the clinical packaging world, our team is empowered to guide you to the best strategic clinical supply solution for your project while ensuring your deadlines are met.
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.
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.
