This video provides an insight into the Biopharma Services Division and how the company helps its customers deliver an efficient and risk controlled clinical supply chain to investigators and patients worldwide.
Fisher Clinical Services provides worldwide distribution, storage, packaging, sourcing, and labelling services to help make the clinical trial supply chain simple and safe.
The company is committed to delivering high-value products, which are adherent to pharmaceutical industry standards, reliable, sustainable, and of the highest performance. Serving any location worldwide, the company helps manage all aspects of the supply chain, including inventory control, labelling, and packaging for drugs, as well as supply chain optimisation, comparator sourcing, ancillary support, storage, and distribution.
In addition, Fisher Clinical Services’ quality assurance team helps guarantee current good manufacturing practices (cGMP) standards are met across all facilities for national and international regulation compliance.
Storage and distribution of ambient and cold chain clinical trial materials
Part of Thermo Fisher Scientific, Fisher Clinical Services utilises a network of current good manufacturing practice (cGMP) facilities globally to support storage and distribution of ambient or cold chain clinical trial materials. These 20 purpose-built facilities are strategically located across 5 continents, further supported by 30 partner depots to provide an efficient service that is compliant with good manufacturing practices (GMP) and good distribution practices (GDP) at all times.
Fisher Clinical Services
Providing flexibility and assurance, this network offers cold chain expertise in the transportation of complex biologics worldwide. In addition to global standards, Fisher Clinical Services’ facilitates local requirements regarding different drug types.
Clinical trial management and partnerships
The company’s professional and dedicated teams offer expertise in managing clinical trials, from protocol design to receipt of materials. Complemented by key knowledge of local and international regulations, the company holds close working relationships with partners throughout the supply chain, with a global reach of more than 150 countries. Fisher Clinical Services’ project managers work with clients to develop a tailored supply chain across all therapeutic indications to serve specific trial needs.
Services offered include packaging, labelling, and relabelling for blinded or open label projects, as well as import and export services, returns and disposals.
Drug sourcing for comparator clinical trials
Fisher Clinical Services’ Comparator Centre of Excellence team helps source biologics for use in comparator trials. These drugs are often one of the highest line items in a study and Fisher Clinical Services helps clients find the right comparator for cost-effective prices through the company’s global sourcing network.
Sourced with full packaging and documentation, drugs such as comparators or investigational medicinal products (IMP), matching placebos, and reference medicinal products can be located and distributed. These are commonly trialled for use in rescue, background, co-medication, and standard-of-care therapies, for small, medium, and large trials. Drugs can be found using central, local, or open market sourcing.
The Comparator Centre of Excellence has employees located at sites in Switzerland, the UK, US, and Asia. Support is also provided to companies throughout Russia, China, Japan, India, and Singapore, supporting clinical studies with reliable drug sourcing, consulting, and full-service procurement.
Packaging for sensitive biological clinical trial materials
Fisher Clinical Services provides high-quality, sturdy packaging to protect sensitive biological clinical trial materials from environmental conditions common in transit, such as changes in temperature, humidity, light, oxygen, pressure, vibrations, and X-ray scanning. The company has expertise in the requirements of timelines, innovation, and specialises in drug packaging. It provides support for biotech and pharma companies, executing small Phase I, Phase II and multi-national Phase III trials.
To ensure patients have access to the drugs they need, Fisher Clinical Services reduces cycle times and allows clinical supply teams to meet tight timelines. The company keeps your critical path in mind, engineering automated solutions to prevent environmental risks and provide a flexible supply chain. This is supported by a global project management team of more than 200 people, solely focused on clinical trials, with expertise in supporting clinical trials of all sizes, global reach and complexity.
Fisher Clinical Services’ packaging is adaptable to meet the requirements of each trial; the optimal configuration expertly advised by the company’s engineering team. The solutions are practical and come complete with temperature requirements and label options for a fully custom design. Whatever the packaging challenge -Fisher Clinical Services’ clients face, the design team makes a thorough review of plans to provide deep insight into best industry practices.
The movement of clinical supplies to investigator sites is becoming more complex and costly. However, a supply shortfall can prevent continuation of an on-going trial, imperilling the programme, and preventing study patients from receiving drugs a sponsor has committed to provide.
Demands for reference drugs, or comparator drugs, are rising as the volume size and complexity of clinical trials reaches record levels.
Comparator Local Sourcing Strategies: Leveraging Advantages and Avoiding Pitfalls for Clinical Trials
Comparators are increasingly used in clinical trials to establish whether an investigational drug is more effective than an existing product, a differentiating factor that can be a prerequisite for licensure, formulary listing, and healthcare reimbursement.
One of the top major pharmaceutical companies approached Fisher Clinical Services for guidance on how to run an ambitious clinical trial in the Asia-Pacific region involving more than ten countries, 74 sites, and 400 shipments across the region.
One of the top major pharmaceutical companies had a high number of studies already in progress in the Asia-Pacific region. The sponsor's required many more studies in this region, but had concerns about its current distribution approach. The Sponsor recognised the need to review its distribution model for existing and planned studies in an effort to realise efficiencies in cost and performance.
The biosimilar market is one of high growth potential for many large pharmaceutical companies, generic manufacturers, biotechnology companies and new market entrants worldwide.
The globalisation and changing regulations of clinical trials has led to the inclusion of many Asia-Pacific countries in the portfolio of target countries for clinical trials today.
A leading pharmaceutical company was focusing its attention on India to conduct bioequivalence studies with clinical end points.
One of the major pharmaceutical companies approached Fisher Clinical Services to discuss a complex request. The company were conducting a double blind study with a light sensitive drug in extremely fragile ampoules. It wanted Fisher Clinical Services to distribute these to investigator sites in remote locations across China.
Fisher Clinical Services' client in Japan had a new compound for clinical development. They wanted to streamline clinical trial deployment, maximise efficiencies, and mitigate risk, with a view to accelerating time-to-market in this highly competitive environment.
Fisher Clinical Services has begun a special feature on its website to help highlight its hard-working project and supply chain managers.
Formerly known as DNA2.0, ATUM has announced it has signed a patent licensing agreement granting Thermo Fisher Scientific access to its novel gene design platform.
Fisher Clinical Services invites you to visit its booth at INSIGHTS East Coast in Philadelphia.
Israel's skilled workforce, adherence to good clinical practice (GCP), and strong patient enrolment and retention rates make this a country-of-interest for clinical research.
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