horsham-web
Thank You for Visiting Fisher Clinical Services, Horsham

A gateway to the world, with seasoned clinical supplies professionals, Fisher Clinical Services Horsham has extensive expertise in handling all types of clinical supplies – from ambient to cold chain biologics, comparator medication, controlled drugs and ancillaries. Our primary and secondary packaging, labelling and logistics experts are dedicated to executing clinical trials of any size and complexity from investigator initiated studies to Phase I studies and larger Phase II and Phase III studies. Involved as early as protocol development right through to returns and destruction, the Horsham team delivers a flexible, efficient and risk-controlled clinical supply chain to investigators and patients worldwide.

Long established (1997) and strategically located in South-East England, the Horsham facility is an intelligence logistics hub with unparalleled expertise in ensuring no Time Out of Environment (TOE) for your clinical supplies. The Horsham team has a track record of excellence in getting your clinical supplies to the right place, at the right time, in the right conditions.

“We welcome you to find out more about the services we provide and the vital role we play in getting innovative new medicines to patients at a time in their lives when they need them the most.”

Astrid Frank, Vice President & General Manager European Clinical Services

Automated global distribution and integrated biologic product capabilities

Horsham Fast Facts:
Location: 40 mi / 65km South of London
Population: 50,000
Nearest Airport: Gatwick Airport (LGW)
Distance from Airport(s) to Facility:
London Gatwick (LGW) 18.2 miles
London Heathrow (LHR) 38.5 miles
London Stansted (STN) 85 miles
Fun Fact: Horsham was home to one of the world’s first “dinosaur hunters” Gideon Mantell, who described and named Iguanodon in 1825 and Hylaeosaurus in 1833.

City:
Horsham
Country:
United Kingdom
Opened:
1997
Total Capacity:
91,500 m3
Primary Rooms:
9
Secondary Rooms:
13
Cold Production Rooms:
12
Warehouse Capacity:
27,812 m3
Ambient Storage Capacity:
10, 759 m3
Refrigerated Storage Capacity (2-8):
16,053 m3
Frozen Storage Capacity (-20):
566 m3
Controlled Drug Storage Capacity:
434 m3
Environmental Technologies:
Yes
Audited:
MHRA
Comparator Sourcing:
Yes
Manufacturing:
Yes
Returns & Destruction:
Yes
Labeling:
Yes
Horsham_sponsor-benefits
Building Collaborative Partnerships That Deliver More
From manufacturing and packaging technology to the automated solutions that introduce time-saving, seamless transition opportunities, Fisher Clinical Services provides Sponsors effective, risk-controlled solutions throughout the entire clinical supply chain.

Key Benefits for Sponsors:

  • Long-established (2007), a reputable provider in defining best practices in the industry.
  • Track record of excellence in managing high volumes of clinical supplies: 1,100+ active studies; 90,000+ shipments annually across 75+ countries, often to very remote locations in emerging regions.
  • A state-of-the-art GMP facility; purpose-built, quality assured and fully audited by the MHRA.
  • Full service line supporting all aspects of clinical trial supply – primary & secondary packaging, labeling, regulatory support, distribution, returns and destruction.
  • Flexibility to handle all types of clinical studies from Phase I to Investigator Initiated Studies (IIS), to the larger, more complex Phase II and Phase III studies.
  • 24/5 Global Logistics Helpdesk supports investigators worldwide every day – proactively tracking and tracing shipments, getting supplies to patients on time.
  • Experienced Qualified Persons (QPs) with a deep understanding of current legislation for all aspects of clinical trial management in Europe, the US and ROW.
  • Expertise in clinical supply chain management, applying a consultative approach across all functions to deliver a solution that best addresses specific needs of a trial.
  • High performance project management teams with immediate access to esteemed colleagues in our strategically located cGMP facilities across the globe – helping overcome regulatory hurdles, customs challenges and infrastructure anomalies.
  • High capacity and expertise in managing cold chain packaging and distribution projects.
  • Ability to handle compounds that are light sensitive and/or compounds with zero tolerance for Time Out of Environment (TOE), as well as handle supplies from -190°C at Fisher BioServices.
  • A continuous improvement mind-set throughout the organization with the application of Practical Process Improvement (PPI) principles, realising cost and performance improvements for Sponsors and facilitating excellence in our everyday working methodology.
  • A Center of Excellence Learning Laboratory dedicated to off-line training of operational employees, keeping them updated on the very latest SOP procedures & best practices in the industry.

Investigator Initiated Studies present challenges as Sponsor strives to access more patients for clinical research

Traditionally, a clinical trial is conducted by a private entity, a biotechnology or pharmaceutical company, the holder of the “marketing authorisation” of the trial product. More recently, however, there has been a noted increase in “Investigator Initiated Studies”, whereby the Sponsor of the trial could be:

  • a person, (a healthcare professional such as a physician or nurse for example)
  • a “not-for-profit” organization, (a government body such as the National Institute of Health)
  • a public institution (hospital, university, trust)
  • a research group

 

In general, Investigator Initiated Studies are smaller in scale and complexity than Phase III trials. At times they establish a proof of concept or are exploratory in nature. The Sponsor is one passionate about continued research in a particular therapeutic area. The benefits from the investigators expertise, creativity, academic focus and resources.

As with the traditional model, the Sponsor is held to the same high standards and adherence to regulations on how to conduct clinical trials. The Sponsor assumes responsibility for initiating and conducting the study; directing the administration of study drug (if applicable); ensuring compliance with all local laws and regulatory requirements; and analyzing and communicating of all study results. Investigator Initiated Studies are supported by numerous companies within the pharmaceutical and biotechnology industry.

Comprehensive Data Gives Visibility and Control
A leading pharmaceutical company, with development focus on a core group of illnesses including oncology, was successfully running clinical trials across the globe with the support of Fisher Clinical Services Horsham. The Sponsor relied on the support of experts at Horsham for packaging, labelling and distribution services for a large number of complex trials, including a global Phase III oncology trial in 2007. The Sponsor had greatly benefited from the guidance of the Clinical Supply Optimization Team at Horsham for this particular trial. The Horsham team handled all aspects of the supply chain from bulk drug receipt through to delivery to end patient, including set up, testing and maintenance of the appropriate IRT service. Cost and performance efficiencies were realized during the trial execution. Data collated over the duration of the trial was comprehensive, allowed greater visibility and control of clinical supplies across the supply chain, and gave the Sponsor the capability to control budgets.

Investigator Initiated Studies
Investigator Initiated Studies were not a core part of the Sponsor’s development plan. However, the Sponsor had to narrow target indications and patient populations in an effort to reduce the increased costs of clinical development. It was thought that the positive data from the investigator initiated studies would give the Sponsor the data it needed to justify further investigator trials of this new, innovative medicine. The Sponsor would seek this expertise from Fisher Clinical Services Horsham.

Study Details
Where: Initially the Investigator Initiated Studies would be in the UK, then Europe, potentially US and South Korea
Type: Phase I and Phase II studies with a variety of dose escalations/findings; open label; double blind; minimisation and stratification trials

The Challenge
The pharmaceutical company had foreseen many challenges with these Investigator Initiated Studies, including:

  • Numerous different investigator teams
  • An identified lack of expertise within the CTU/Investigators concerning various aspects of clinical supply management, including drug supply
  • Inconsistent drug supply of this particular medication – complex, with multiple expiry dates and, at times, very limited supplies
  • The need to manage budgets

 

The Solution
The Sponsor was confident that these Investigator Initiated Studies would run more smoothly with the support of the Clinical Supply Optimization team at Fisher Clinical Services Horsham. The expertise of the team at Horsham would:

  • Provide overall management of the design of IRT around drug management modules
  • Monitor performance of the IRT
  • Change parameters in the IRT as and when necessary
  • Provide forecasting across various protocols to allow planning of bulk requirements
  • Review protocols before final sign off to negate the need for protocol amendment
  • Manage all aspects of labelling including design and adherence to regulatory requirements primarily in the UK, but also in other countries

 

The solution resulted in savings on drug overage, true visibility of supplies across the supply chain and realized efficiencies in cost and performance.

Success
The success of the first two protocols managed through Investigator Initiated Studies in 2009 prompted the pharmaceutical company to embrace Investigator Initiated Studies as a means to continue clinical research in this therapeutic area. Fisher Clinical Services mission was to get uninterrupted drug supply to patients at the right time, in the right place and in the right condition. This was achieved for over 1,600 patients. Fisher Clinical Services Horsham continues to support this Sponsor for all Investigator Initiated Studies on oncology and on other disease indications.

Drug Product Sensitivity requires innovative packaging and distribution solution

Our client, one of the top major pharmaceutical companies, approached Fisher Clinical Services Horsham with a challenging study – a large, double blinded Phase III study involving precise syringe compilation with need to find an optimal packaging solution for transportation of supplies across multiple countries. Two additional complexities were identified: the IMP was extremely light sensitive and temperature sensitive, and timeframes were tight with FPI date looming. Having worked with Fisher Clinical Services Horsham before, the Sponsor was confident that a solution would be found to address these complexities. There was an expectation that Fisher Clinical Services Horsham would provide the following services – packaging component design, labelling, packaging, distribution, returns and destruction.

Challenges faced for Fisher Clinical Servies:

  • The IMP was filled into a syringe and for blinding purposes the plunger rods had to be replaced. The position of the plunger rod was essential as any movement would impact the sterility of the IMP. Precision was paramount.
  • The appearance of the active drug (IMP) and the placebo drug had to be identical
  • The IMP was temperature and light sensitive, requiring special considerations for packaging, labelling and distribution
  • As this trial was to be conducted in multiple countries across the world, careful consideration had to be given to how the IMP would be transported globally and the best way to overcome any impact of air pressure when transporting the product by air
  • Time was of the essence as the packaging volume was large with the FPI (First Patient In) date looming close

 

Team Collaboration
Fisher Clinical Services Horsham nominated team members from across all departments to work together to find solutions to address the complexities of this trial. In an effort to shorten the project timeline regular update meetings were scheduled with the Sponsor so that everyone was involved in making decisions on customised packaging, labelling, distribution processes for this particular trial. As Fisher Clinical Services has been solely focused on clinical trials for over 25 years, with Subject Matter Experts in Horsham and in our strategically located GMP facilities across the globe, a creative and innovative packaging and distribution solution was defined to address the complexities of this trial.

Engineering Innovation leads to new packaging design solution
From the outset, all team members understood the complexities of the drug product and the parameter dynamics of working with these supplies. It was confirmed that the sterility of drug needed to be maintained at all times. The sterility of the IMP in the pre-filled syringes would become compromised if the plunger rod movement was out of the tolerated range. To this end, the Fisher Clinical Services team of engineers developed new technology that would monitor and detect the plunger rod position, using automated technology, and removing any reliance on using the human eye to gauge accuracy of the position. Any syringes that failed to meet the defined parameters for plunger position were rejected on the line before it exceeded the tolerance level. These rejected syringes were then reprocessed ensuring that there was no unnecessary wastage of valuable drug product and ancillaries for the Sponsor.

The result is a new solution that can be utilised globally in both ambient and cold conditions, also known as ProSyries, providing quality and innovation to syringe assembly. This solution:

  • Reduces variability and risk through quality driven, global, automated processes and equipment
  • Maximizes flexibility to meet the needs of every trial and every syringe. This quality-driven automated and semi-automated processes can meet the needs of multiple fill sizes
  • Safeguards patient and medical staff
  • Eliminates bottlenecks and delivers efficiency

 

Design solution to minimize movement in transit
Secondly, delivery of these pre-filled syringes intact presented another challenge to the Horsham team as these supplies were included in protocols involving multiple countries across the world, hence involving air travel. The team of engineers at Horsham approached this challenge by running tests with direct comparisons on atmospheric conditions in a vacuum chamber environment.

An innovative tray was designed to eliminate the plunger rod movement in the atmospheric conditions that the IMP would face during air transit. Samples of this tray were designed and developed in-house, using cutting edge 3D technology and simulation software. These samples were used as a proof of concept so that the Horsham team could approve and validate the design before producing large supplies to accommodate the quantities needed for this large trial.

Eliminating Time Out of Environment (TOE)
An important complexity to address was the fact that the IMP was extremely sensitive to both light and temperature. It was determined that the IMP could not be exposed to ambient conditions or to direct sunlight during packaging or distribution as this would impact on product sterility. The Fisher Clinical Services Horsham facility benefits from being able to receive drug into the regulated and controlled cold chain warehouse at 2 – 8°C. In addition, processes for packaging, labelling and for pack down into validated cold chain shippers, all within the 2-8°C environment.

To overcome the challenge of light sensitivity, the Horsham engineering and operational team of experts devised a solution to convert the packaging rooms in the cold chain environment to block out any light sources and to product from light to industry standards of <500 nanometres, which includes UV rays.

To this end, the IMP was maintained at 2 – 8°C throughout all packaging, labelling and distribution processes with no Time Out of Environment and zero excursion to ambient temperature and light.

In Summary
This complex packaging, labelling and distribution project presented many challenges for the Sponsor which in turn provided an opportunity for Fisher Clinical Services to deliver innovative solutions to address these complexities. With a sole focus on clinical trials for over 25 years, a dedicated team of experts at Fisher Clinical Services through the use of cutting edge technology and creative thinking, was able to successfully execute the packaging, labelling and distribution requirements of this large, complex Phase III trial across many countries.

In fact, online speed and efficiencies were increased by an impressive 66%. All supplies were delivered On Time and In Full without compromise to patients. This demonstrates that innovation, expertise and operational excellence were paramount to the success of this trial.

Sponsor realizes cost ($10.2m per year) and performance efficiencies (increased OTIF by 4%) with innovative transportation solution

Our client, a leading multinational pharmaceutical company with a true commitment to delivering innovative medicines and to achieving clinical excellence, approached Fisher Clinical Services with an extensive clinical trial pipeline and the need to achieve a comprehensive, fully managed transportation strategy. This Sponsor believed that by outsourcing the transportation element of its clinical trials, its own teams could focus on what they did best – further developing new medicines across many therapeutic areas that could make a meaningful difference to patients’ lives across the globe.

Key Objectives:

  • Optimise transportation costs
  • Maximize OTIF delivery to all global locations
  • Deliver enhanced site satisfaction
  • De-risk the supply chain
  • Secure chain of custody of supplies at all times
  • Reduce burden on the Sponsor’s internal study management group
  • Proactively forecast & manage budgets

 

The Sponsor took time to evaluate many potential distribution partners. After an extensive period of research and evaluation, there were 3 key reasons for choosing to partner with Fisher Clinical Services:

1. A cGMP facility network, unparalleled in the industry
2. Unique, innovative, data driven logistics expertise
3. Sophisticated investigator site support

Also driven by the desire to achieve cost and performance efficiencies across a comprehensive pipeline of many global trials across many different therapeutic areas, the Sponsor felt confident that Fisher Clinical Services would deliver on this and would work closely with its in-house study management teams to continuously improve on defined metrics of measurement at all times.

The Solution
In order to best service this Sponsor a global cross functional team was established solely dedicated to this Sponsor alone. This cross functional team was founded on specialists from IT, Quality, Project Management, Engineering, Operations and Finance, with defined contact points with external logistics companies across the globe. Further strengths of this dedicated group included its access to industry leading logistics expertise, brokerage services, Global QA and Regulatory support and local, on-the-ground, expertise within each region via the Fisher Clinical Services wholly-owned global footprint.

1. Facility network
The Sponsor recognized that the Fisher Clinical Services fully-owned network of cGMP facilities strategically located across the globe was unparalleled in the industry. This network of owned facilities linked through a common IT platform and global logistics SOPs, augmented by an extensive third party depot network, would offer the Sponsor a comprehensive footprint capable of receiving, storing and distributing clinical supplies to any location across the globe.

The capacity and specialty storage and handling conditions available at the cGMP sites assured the Sponsor flexibility in servicing multiple studies with varying IMP requirements, including the capability to manage scheduled and temperature-controlled drugs. Fisher Clinical Services’ on-site labeling capabilities introduced another level of flexibility not provided by other potential partners.

2. Unique, innovative logistics expertise
The Fisher Clinical Services unique and innovative solution, Total Transportation Management Service, includes complete oversight of the supply chain processes required to move IMP shipments internationally and within the country of destination, including:

  • Courier selection and management
  • Customs and regulatory guidance
  • Storage and distribution facilities
  • Oversight of third party depot shipments
  • Global quality assurance support
  • Proactive track and trace of all shipments

 

Fisher Clinical logistics experts worked on a dynamic model of courier selection, using the data to allow them to choose the most effective courier based upon raw performance data. The solution was built on a fixed cost model allowing the Sponsor to receive preferential standard and premium freight rates, preferential global facility and depot rates and fixed fuel surcharges which helped them predict and manage their project and department costs.

Project Management and Logistics experts:

  • Analysed trial protocols
  • Consulted up-to-date logistics knowledge database
  • Evaluated data on couriers
  • Applied data driven objectivity to route & courier choice
  • Defined supply chain strategies to achieve maximum % of OTIF shipments & to realize cost efficiencies

 

Resources were dedicated to tracking and measuring courier performance over time with the ability to provide reports and updates in real-time to the Sponsor. This type of enhanced visibility, enabled by Fisher Clinical Services proprietary systems, allowed Sponsor teams around the world to understand the status of their shipments and to validate performance statistics based on a common set of measurements and matched to actual investigator site delivery. This data driven objectivity was considered unique in this industry.

In addition, clear metrics were defined. The objective of this data driven approach was to maximize the On-Time- In-Full (OTIF) receipts and reduce the overall costs while mitigating risk across the supply chain.

3. Investigator site support
The Global Logistics Helpdesk teams based in Allentown, PA, USA and Horsham, UK were made available 24/5 to the Sponsor’s global teams and to investigator sites across the globe, providing proactive track and trace reporting on all supplies. The level of service offered to the investigator sites was particularly high with a can-do attitude and the ability to intervene if shipments were at risk of not being delivered at the right time, to the right place, and in the right conditions.

Changes to original transportation strategy
One key impactful change to the Sponsor’s transportation strategy was a new approach to courier selection. It was decided that all couriers would now be monitored through the Fisher Clinical Services Global Logistics Helpdesk. All clinical shipments across all routes and regions would be analysed in detail. The on-time performance of 20+ couriers across 120+ countries would be monitored not only for OTIF results but also for cost of service.

This new and novel approach recommended:

  • To use the most effective Integrator couriers where there would be no performance degradation
  • To evaluate and use the most effective Premium couriers with specialist brokers to maintain chain of custody in transit

 

This data-driven courier selection would significantly optimize cost and performance efficiencies for this Sponsor.

The results were phenomenal
The results showed significant cost savings were achieved year-on-year. Previously the Sponsor would send circa 32% of its clinical shipments via Premium Courier. The data driven objectivity applied by Fisher Clinical Services reduced this % of premium courier shipments to just 7% which resulted in significant cost savings of circa $10.2m per year. More importantly there was no degradation in performance. In fact, it improved across the supply chain. OTIF % increased from 93% to 97%, which is a win-win situation for the Sponsor and the patients.

Over time the Sponsor teams have become well versed in the breadth of services provided by the extensive global Fisher Clinical Services network of facilities. The Sponsor has been able to expand its reach through leveraging Fisher Clinical Services’ footprint and local expertise to guarantee delivery to any site in the world, including remote and challenging locations.

Meaningful KPI reporting and analysis has enabled a culture of continuous performance amongst the Fisher Clinical Services logistics team and the Sponsor team. Now that global processes have been standardized from study initiation through to returns and destruction, the clinical trial transportation strategy is a smooth one. In addition, the Sponsor’s investigator sites and CROs have access to the Global Logistics Helpdesk to track and trace all shipments. This means that the Sponsor can focus on other high value activities, i.e. developing innovative medicines that will impact patients’ lives.

Multiple global trials and limited product availability requires innovative solution

Our client, one of the world’s leading Biotech companies approached us with a need to find an innovative solution – how to service multiple global studies whilst not adversely affecting the limited inventory of available drug.

Challenges
This biotech company, having worked with Fisher Clinical Services Horsham in the past, clearly vocalized their known foreseen challenges:

  • Increase in volume of trials to be executed over a defined period of time
  • Multiple protocols running in over 30 countries in all regions of the world
  • Additional complexity of supporting inexperienced investigators
  • Need to respond quickly to patient needs due to short enrolment period with limited availability of costly drug
  • The prospect of high overage due to difficult to predict demand

 

Innovative Solution Needed
Through a global cross functional team founded on specialists from IT, Quality, Project Management, Engineering, Operations, Finance, and external Vendors, Fisher Clinical Services Clinical Services Horsham defined a new, quality assured global process that could be effectively rolled out across our network of strategically located GMP facilities across the globe. This new solution would have to be robust adhering to our GMP standards and to additional quality measures defined by our Quality Teams across the network.

This innovative solution would involve pooling supplies within the Fisher Clinical Services’ Facility Network with regional facilities set up to provide maximum flexibility of inventory to meet the needs of the study. It would allow labels at the study, component, and country level to be applied at the point of despatch before being shipped directly to the investigator.

Fisher Clinical Services identified the need to secure a mandate of support from the MHRA as these clinical supplies would be used for multiple protocols across 30+ countries. After a thorough analysis of this new approach and with approval from the MHRA secured, Fisher Clinical Services embarked on making significant investment in infrastructure and on leveraging our existing IT platform to accommodate the unique nuances of applying this new approach to managing inventory and executing despatch of clinical supplies in a short timeframe.

This unique solution has delivered a controlled process ingrained into Fisher Clinical Services systems that allows information normally controlled within a Production Order to be applied at point of despatch. Fisher Clinical Services Operational Teams across all facilities are trained to this new way of working.

The Benefits

  • MHRA approved, system based solution with global coverage
  • Maximum flexibility of high value and/or limited inventory IMP / Comparator
  • Reduction of overage and the impact of a short shelf life
  • Last minute decision making of when to commit inventory to a patient
  • Rapid turnaround of shipment requests direct to site

 

The Results
Fisher Clinical Services Horsham ensured security of supply for 10 different drugs used across 43 different protocols. In addition, Fisher Clinical Services Horsham ensured that each trial met the regulatory requirements of all 32 countries involved, with the capability of turning around a shipment request in 3 working days to accommodate patient schedules. Over time the Sponsor reduced overage by a further 150% from an initial assessment of 70%.

The Future
Fisher Clinical Services can now apply this flexible solution to a variety of study designs servicing the innovative solutions being requested by this biotech company and indeed by other Biotech and Pharmaceutical companies facing similar challenges to those outlined above.

QP expertise facilitates EU clinical trials with non-investigational medicinal products (NIMPs)

Investigational medicinal products are well understood and defined within the European Union under Directive 2001/20/EC. However, clinical trials today often involve other products that, although used in the trial, are not the object of investigation. These medicinal products do not fall within the definition of investigational medicinal products and are called “non-investigational medicinal products” (NIMPs). They are supplied to aid the trial. For example, a rescue medication where a phase III clinical trial is trying to assess the efficacy of a new anti-neoplastic IMP. All patients receive a corticoid /antihistamine treatment in order to minimise the appearance of expected adverse reactions.

The importation and release of these medicinal products is not well defined universally across the EU, when they are imported from outside the EU. EU/UK legislation requires that any importation and supply of products that do not hold a license in the EU must be supplied in the UK under ‘’special’’ /unlicensed arrangements, which has very specific stipulations for number of doses and very specific requests from clinicians.

In most circumstances, it is expected that a NIMP is sourced and supplied by the Sponsor within the EU. However, this is not always the case.

Challenges
Our client, a leading pharmaceutical company was planning to conduct a Phase III study requiring adjunctive therapies for anti-depressant disorders in the EU. The preferred distribution strategy was to import all supplies into the UK initially, and then supply the various competent authorities throughout the EU. This US-based Sponsor incorrectly assumed that NIMPs already sourced in the US could be released in the EU without further documentation.

Understanding Legislation
Understanding the legislation and liaising with the competent authority early in the planning stage were key factors for success with this trial. Fisher Clinical Services stipulated that:

  • Importation of non-EU NIMPs is not covered by any importation licence in the EU
  • The legislation surrounding the importation and use of NIMPs is variable across the EU
  • A strategy of supply would have to be agreed in advance as there is no QP release of NIMPs

Fisher Clinical Services Horsham convened a team of experts to conduct a technical assessment of the trial requirements with particular focus on the complexities related to the importation and exportation of NIMPs in the EU. This team comprised of Qualified Persons (QPs) and other senior clinical operations team members. Their extensive knowledge and expertise resulted in a quick and efficient technical assessment of what was needed to facilitate the requirements of this clinical trial.

The options for importation and release were assessed by the technical group.

horsham case study photo

A systematic elimination of importation and release routes were discussed.

  • The product was not an IMP. The Manufacturing Import Authorisation (MIA) IMP license could not be used.
  • The MIA for commercial products could not be used either, as the Product license was not held by Fisher Clinical Services.
  • The specials route could only be used with specific requirements such as limited quantities and only by unsolicited requests from clinicians. Specials legislation is specific to the UK and provides a method for otherwise unlicensed medicines to be supplied to patients under very specific circumstances.
  • The only route was to discuss the specific legislative requirements with the UK competent authority. Fisher Clinical Services was best positioned to leverage technical expertise and contacts within the competent authority to agree a solution. A novel route was explored and successful agreement with the competent authority achieved. This demonstrated a ‘thinking outside the box’ mentality, and an agreement to apply a flexible and compliant approach to this issue. It was agreed that the specials license would be used, but outside the usual method. The CT Approval would be used in place of Clinician of US sourced NIMPs.

 

The Solution
The Sponsor’s concerns as to how the NIMPs could be released were alleviated. Fisher Clinical Services Horsham showed drive and commitment in resolving this issue. The Horsham team:

  • Opened discussion with the UK competent authority.
  • Agreed a novel proposed importation/exportation method with the UK competent authority. Resolved the importation issue using a non-standard view on the ‘’specials’’ process.
  • Provided timely feedback and communication to the Sponsor on progress with the UK competent authority.
  • Provided overall management of the importation and supply of product, leveraging the expertise of the QP group onsite.
  • Submitted all relevant documentation and details facilitating importation and release of NIMPs.
  • Provided QP overview and release of product OTIF (on-time and in-full) of all NIMPs. All products were supplied to clinical sites with no delay to the trial.

 

The Results
Without the expertise of the QP services at Fisher Clinical Services Horsham, the Sponsor may have had to re-source the NIMPs within the EU. This would have taken a lot of time and effort, not to mention expense.   Technical expertise was at its best with all parties working together to ensure adequate supplies were ready for delivery as per protocol guidelines

  • Agreement with competent authority on how to handle NIMPs in the EU.
  • Clear communication between the Sponsor, Fisher Clinical Services and the competent authority.
  • Effective on-going management and control of the entire investigation.
  • Supply of all NIMPs compliantly and efficiently, OTIF to investigator sites throughout the EU.
  • Savings achieved as the Sponsor did not have to re-source NIMPs within the EU

 

QP Services
Fisher Clinical Services offers comprehensive services for the preparation of QP Declarations and performs supporting audits that may be required. All Fisher Clinical Services QPs are trained as ISO Lead Auditors and have extensive experience in auditing facilities across the world.