Marken is conducting a survey on Clinical Supply Chain Quality Management and we would love your feedback. Respondents will receive a copy of the survey results. To participate, fill out the form below, and we'll get you set up.
The Leading Life Science Logistics Specialist™
Founded in 1980, Marken is focused on supporting Life Science companies assure the quality and integrity of clinical trial specimens and vital medications through the logistics chain. For nearly two decades, Marken has extended the reach of Pharmaceutical companies, research laboratories and clinical trial research organizations bridge the distance between patients and life science investigative resources.
Clinical Trial Product Biomanufacturing and Packaging Logistics
Life Science products have a distinct logistical profile; the nuances between a fine chemical and a medical compound have significant regulatory differences. Specialists are able to proactively mitigate issues, protect the integrity and assure delivery in the needed timeline. Marken contributes the expertise to prepare Clinical Trial Logistics Protocols for the transport of APIs, selection of optimized cold chain packaging systems to final clinical trial drug and device distribution. Marken, by means of cross industry specialists working together, delivers custom logistic solutions securing the quality of pharmaceutical and Biological entities through the supply chain.
Clinical Trial volunteers place their health and safety in the hands of researchers, investigators and laboratory scientists. Marken provides expertise in the collection, packing, logistics and global transport regulatory process of trial specimens connecting the trust points to protecting patient safety as well as research integrity. Life Science Logistics Specialists are able to span the quality gap of transporting specimens to assure the accuracy and efficacy of novel biomarkers in global trials.
Clinical Trial Product Protection and Efficacy
Drug manufacturers and research companies have relied on Marken’s assistance and guidance to help plan and protect valuable clinical trial assets through the supply chain. The level of required expertise of storage, care and distribution of clinical trial supplies is increasing in both complexity and regulatory expectations. To support our clients, Marken has invested study drug distribution experience in protecting Large and Small molecule products into our flagship Singapore depot and in further strengthening our global depot network to exceed global guidelines. These facilities are becoming the keystone in managing the quality and inventory of high investment clinical trial products as well and protecting the efficacy of sensitive drugs.
Marken understands the specialized and dynamic needs of the life science Industry; we retain our global agility by continuously investing in our people, technologies and global installations to better support our clients.
With over 400 people in 24 offices spanning the world, Marken has the expertise to ship globally and deliver locally to investigator sites or directly to patients.
Our state of the art management, tracking and information systems are second to none offering our clients real time visibility to the last mile. From hand to hand our chain of custody reflects our dedication to supporting and exceeding our client's expectations.
The combination of Expertise, Agility, and Resources are complemented by our dedication to supporting our clients, their patients and the many lives that depend on our services.
Marken Supports Life science companies by:
- Developing point to point transport schedules to protect asset stability windows and thresholds.
- Extending the reach of Life Science companies supporting sites, patients and manufacturers to mitigate logistic risks.
- Enabling continuous temperature monitoring and management expertise from pick-up to delivery including rapid retrieval of temp tales and transfer of data.
- Managing pre-clearance through customs whenever possible to protect valuable assets and timelines.
- Global availability 24 hours a day, 7 days a week including weekends and holidays to help resolve issues and assure responsive care.
May 30, 2013 - Princeton, NJ
A presentation of the latest regulations & guidelines, driving the need for QA's
*Attendance and participation is complimentary*
-What is a quality agreement and why should you have one?
-Content of a quality agreement and minimizing inconsistencies & conflicts
-Legal & regulatory issues to consider relating to quality agreements
-Good Distribution Practices (GDPs), Current Good Manufacturing Practices (cGDPs) & Quality Systems Regulations (QSRs)
- President, Global BioPharm Solutions
-President, American Society for Training & Development (ASTD), Philadelphia Chapter
Rafik H. Bishara, Ph.d.
-Chair, Pharmaceutical Cold Chain Interest Group (PCCIG), Parenteral Drug Association (PDA)
8:30 am - Registration and continental breakfast
9:30 am - Workshop
1:00 pm - Buffet lunch & networking
Claire Fleming RSVPMarkenEvent@marken.com