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.
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.
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.
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.
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.