Help sponsors design a more holistic strategy to their managing the clinical supply returns process.
In addition to careful adherence with all applicable regulatory and Customs requirements, sponsors should understand and be sensitive to the cultural and business norms of each country included in their study.
It is up to pharmaceutical companies sponsoring clinical trials in the EU to have complete control of their supply chain. Understanding recent changes to the EU GDP guidelines can help achieve this as they now offer a more comprehensive guidance for temperature management during storage and transportation.
These clinical packaging strategies can be used to help successfully manage the supply of an expensive drug product throughout the duration of clinical testing. Without doing so, there could be costly interruptions or extended delays that would have a devastating impact on a company’s timeline to commercialization.
How a powerful forecasting and demand planning technology for managing the end-to-end clinical supply chain can quickly simulate the most common scenarios for each step of your study, create a study baseline and forecast randomization into different dosing groups.
Contracting an in-country clinical depot helps bring costs and timelines under control.
While Andexanet Alfa’s Breakthrough Designation added additional stress to the supply chain, Portola and Sherpa navigated these issues by devising fast, flexible and responsive approaches to supply chain management.
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.
When time-reduction, cost-savings, quality and reliability matter, ropack pharma solutions is the distribution partner positioned to deliver.
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.
In its 2013 annual listing of the top 100 healthcare information technology companies, Healthcare Informatics magazine has placed Cognizant at number 6. Cognizant ranked sixth in 2012 as well. Cognizant’s ranking marks the twelfth consecutive year the company has appeared on the list.
DATATRAK International, Inc. (OTCQX: DTRK), a leader in developing cloud-based, unified eClinical® technologies and delivering related services for the clinical trials industry, today announced its operating results for the first quarter of 2013.
Cognizant has jumped 46 places in the FORTUNE 500, which was released on May 7, 2013, and is based on revenue for the 2012 fiscal year.
NextDocs announced the release of NextDocs 6, the latest version of its award-winning regulated content management and compliance suite.
On February 15, 2013, the Board of Directors of General Electric Company elected Cognizant CEO Francisco D’Souza to its board of directors.
Cognizant recently announced that it has been positioned as a Leader in the IDC Health Insights "IDC MarketScape: Worldwide Life Science Drug Safety Services 2013 Vendor Assessment" (document number HI239221, dated February 2013).
Immunovative, Inc. ("IMUN" or the "Company") (OTCQB: IMUN) announces today that Immunovative Therapies, Ltd. ("ITL") has been granted regulatory clearance from Thailand authorities to advance its lead AlloStim™ immunotherapy product candidate to the Phase II/III clinical development stage in advanced metastatic breast cancer.
TAKE Solutions, a leader in the Supply Chain Management (SCM) and Life Sciences (LS) domains, recently announced its next release of OneSCM, a multi-enterprise collaboration suite for managing extended supply chain operations.
Marken announced recently that it continues its expansion in China to meet the anticipated need for increased clinical trials logistics services.
Marken passed an important milestone on 20 August 2012. With the launch of two new pharmaceutical depots, one in Germany and one in New York, the organisation successfully completed phase I of its global depot network plan.
A free Marken webinar hosted by Jay Hayer and Rey Reynaldo on September 19th is now available as a download. “Beyond BRICs — Operational and regulator insights for working in Vietnam, Central Africa, Middle East, and Malaysia.” You can download the recording for free (with registration). We invite you listen and share the download with colleagues and business partners.
Marken announced recently the completion of the first phase of its plan to create a global pharmaceutical depot network that will allow it to satisfy its client’s needs for global distribution.
Marken announced recently the opening of four expanded branch facilities to meet the continued growth of their business.
Sitrof Technologies, a premier provider of IT, consulting and technology solutions for life sciences companies, is pleased to announce the addition of Jay Rothe as Vice President of Business Development.
