We are Consultants specializing in Cell & Gene Therapy/Regenerative Medicine. Our Pharma Bio and now C> experience brings us the knowledge of “What Works & Doesn’t Work”. As consultants, we bring the knowledge and understanding of the process that is needed to digitize and be able to obtain the data to effectively and efficiently run the business. This is particularly important considering the complexity of the C> and Regenerative Medicine Supply Chain!
We bring value to your organization by facilitating assessments of your systems, analyzing the output, and identifying next steps to optimize and ensure long-term success of your business engineering, re-engineering and technology investments.
Hypertrust provides specialized solutions and consulting services to optimize the supply chain of ATMPs (Advanced Therapy Medicinal Products). Hypertrust’s products and services support all product lifecycle stages from pre-clinical trials to commercialization. With Hypertrust’s broad supplier and service provider ecosystem, companies can accelerate the setup of their ATMP supply chain processes. Hypertrust is part of Elixum, a Camelot Group Company.
Converge Consulting is a Boston, Massachusetts-based consulting firm with specific expertise that improves effectiveness for cell therapy operations. We specialize in strategy, operations, and execution for life science companies throughout the product lifecycle (preclinical à clinical à newly commercial à mature). Our team of 50+ seasoned industry leaders across Supply Chain, Manufacturing, Quality, CMC, Commercial Launch, Finance, and Enterprise IT Solutions collaborate with cell/gene therapy, biotech and pharmaceutical companies to achieve your important business objectives.
FTI Consulting’s Life Sciences division has deep expertise and experience in supporting early-stage, late-stage and commercial Cell & Gene Therapy manufacturers in establishing Core Operations that are scalable and meeting the time-criticality requirements of your therapies. Our team consists of Operations, Regulatory and Quality experts that have guided many organizations of any size through the complexities that C> bring. FTI Consulting also functions as financial, communications and compliance advisor and can help you establish financial partnerships, communicate on key life events in your company, and guide you through compliance challenges along the way.
Established in 1984, MAK-SYSTEM is a cutting-edge technology company specializing in software solutions for blood and plasma establishment, transfusion management, and cell therapy orchestration. We develop, design and deliver the best technologies and functionalities for every patient’s benefit. With a track record of innovation, MAK-SYSTEM offers comprehensive solutions for managing the entire lifecycle of biological products. MAK-SYSTEM's solutions ensure compliance with regulatory requirements, improve operational efficiency, and enhance patient safety.
TrakCel is the first provider of integrated cellular orchestration solutions for the precise management, control and tracking of cell and gene therapy products. With the largest number of live deployments supporting the broadest number of therapy classes in industry, TrakCel has built a deep understanding of the unique challenges faced by advanced therapy developers globally.
OCELLOS by TrakCel is a powerful, integrated cellular orchestration solution for the precise management, control and tracking of advanced therapy supply chains, patient by patient. OCELLOS supports autologous, allogeneic and personalised cancer vaccine therapies at all clinical and commercial stages whilst OCELLOS Lite has been developed for quick, cost-effective deployment for early-stage clinical therapies. Our brand-new product OCELLOS Core is an out-of-the-box Chain of Identity and Chain of Custody solution for therapy developers from first in human clinical trials.
Serving pharma, biotech and hospital treatment centers, Comprehensive Cell Solutions provides deep expertise in the development and manufacture of cell and gene therapies. CCS supports preclinical through commercial phase products with process and analytical development, GTP, and GMP facilities located in New York City, Houston, TX and Louisville, KY. Spanning cell sourcing and apheresis, cell isolation, manipulation, and cryopreservation, its unique Draw-to-Thaw™ portfolio combines one-stop service to introduce efficiencies across the CGT value chain.
World Courier, now part of the Cencora family, provides specialty logistics services to drive the clinical and commercial success of our partners around the globe. We deliver peace of mind through world-class supply chain programs, transport services, decentralized clinical trial support, and storage for time- and temperature-sensitive products, including innovative medicines like cell and gene therapies. Our global network of dedicated team members, monitor the safety and integrity of your product proactively, ensuring it reaches patients without delay. We plan for contingencies, so you don’t have to, leveraging our global capabilities and local, on-the-ground knowledge to navigate logistics complexities.
For 43 years, QuickSTAT has been providing the leading pharma and biotech companies 24/7/365 global life science logistics solutions from R&D, clinical trials through to commercialization.
Our logistics experts provide time- and temperature-sensitive transport of clinical research samples, cell and gene therapies, investigational drugs, clinical trial supplies and vaccines, to bring new drugs to market. Strict chain of custody, chain of identity and GDP protocols ensure product integrity and patient safety for all clinical and commercial personalized medicines QuickSTAT transports. Consultation and procurement of proper packaging—from controlled room temperature to cryofrozen. Next gen IT logistics software provided for managing your clinical supply chain with real-time temperature and tracking technology.
YSDS Life Science manages advanced shipments for Life Science products, including global logistics solutions for research and development, clinical trials, advanced therapy, biotech and commercial drugs. We offer tailormade GDP-certified solutions for your time and temperature-sensitive products, with full end-to-end visibility.
Bluecrux is a leading value chain technology and consulting company, providing solutions at “the Cutting X”. Bluecrux experts and software help to transform today’s supply chains into smart, efficient, and fully integrated value chains. Bluecrux offers solutions that fit the unique complexities of businesses in life sciences, consumer goods, chemicals and industrial manufacturing.
Binocs is #1 SaaS solution for scheduling and planning has been specifically designed to address the challenges in Cell & Gene Therapy industry. Binocs can assist therapy developers in efficiently manage internal and external resources to create a great customer (HCPs) and patient experience by providing real- time updated and information on the development of individual therapeutics. Binocs is already supporting commercial CAR-T and many other late & early stage clinical studies
Arvato is 100% daughter company of Bertelsmann - a media, services and education company that has 165,000 employees worldwide and generated revenues of €20.2 billion.
Arvato specializes in providing comprehensive supply chain services for the healthcare industry and tailored specifically for the Cell & Gene therapy sector. We seamlessly integrate solutions, ensuring a streamlined and efficient process, based on a unified SAP IT backbone.
Drawing on our deep understanding of the healthcare industry, combined with our extensive knowledge of processes and IT systems, Arvato develops customized outsourcing solutions for our clients. By bridging the gap between our clients and the point of care, we bring them closer to their patients, ultimately enhancing the delivery of Cell & Gene therapies.
Biocair is a global GDP logistics specialist with over 35 years of experience in the pharmaceutical, biotechnology and life sciences sectors.
By assembling a team of best-in-class industry experts in quality, cold chain and regulatory compliance, Biocair focuses on providing the most comprehensive time-sensitive and temperature-controlled solutions.
Peli BioThermal offers the widest range of temperature-controlled packaging and service solutions to the global life sciences industry, including a complete portfolio of services and software to support end-to-end temperature-controlled packaging. From discovery to distribution, our products ensure that delicate life science materials arrive intact and effective. Customers trust us with their most valuable health-giving and life-saving products because of our expertise in ensuring temperature stability is maintained throughout the distribution chain and for our ability to meet them wherever they operate globally. The economic value we bring our customers is total cost of ownership for all our owned or rented packaging, services and technology offerings.
time:matters specializes in flexible, sustainable and worldwide door-to-door transport services that are customized to suit your unique needs. With our exclusive and global network, we guarantee the reliable and transparent transportation of your shipments, utilizing the fastest routes available by air, rail, or road. Our team of experienced logistics experts take care of every step in your supply chain, including collection, customs clearance, and final delivery. Whether you require urgent delivery of medical samples, dangerous goods, or confidential documents, we provide transport solutions for emergencies and time-critical regular business. Our dedicated team is available 24/7 to provide personalized support.