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European Biopharmaceutical Review

The Enhanced Solution

Samantha James of Simbec Research reviews the advantages of using a central laboratory service within a Phase I environment

The central laboratory service is forever changing. The ongoing commitment made by sponsors and CROs to improve the overall accuracy and efficacy of the drug development process is resulting in an increase in the complexity of clinical trials. As the complexity of clinical trials increase, the need for access to additional scientific expertise is emphasised as the request for esoteric testing and specialist services, such as biomarker and imaging services, also increases. This can become difficult for many laboratory providers and full service CROs who simply do not have access to such expertise on site. In order to overcome this hurdle, acquisitions are being made and new partnerships are forming between CROs and specialist service providers to enable them to remain competitive within this aggressive market.

Using multiple providers to offer one complete service also means numerous approaches to quality, logistics management, data capture, study management and reporting. The level of quality in these areas, in addition to the quality of the service overall, is often diluted – an area which is not a problem if using a full service CRO able to provide all services on one site.

Although full service CROs have been around for many years, very few are able to fulfil all study requirements – for example bioanalytical, data management and project management – from one main site. This is a niche market which has been recognised and targeted by several CROs who have built long standing, reputable businesses by centralising services, providing sponsors with a complete service solution performed at one site. This ensures full control of quality throughout all areas of the business from recruiting of volunteers through to the reporting and management of data.

HOW DOES A CENTRAL LABORATORY WITHIN A PHASE I FACILITY ADD VALUE?

There are many answers to this question as summarised within this article. It is the ongoing commitment of a full service CRO to maintain high levels of quality, expertise and access to additional supporting services, which enables areas such as the central laboratory to be promoted as a stand alone expert service supporting external studies as well as those conducted in-house.

QUALITY

All CROs should recognise that quality is a fundamental aspect of the clinical trial. In-house quality assurance is a key factor which indicates the CRO’s level of commitment to quality within their organisation.

In order to maintain a good reputation within the industry, it is important that the full-service CRO retains well respected quality standards. Achieving high quality standards (for example GCP, GMP and GLP) and maintaining them through regular, successful audits is not easily achieved. This requires commitment from all areas of a company, including specialist services such as the central laboratory.

To provide a competitive edge, the full service CRO will go beyond these quality requirements and seek additional awards, such as the Standard and Supplementary MHRA accreditation within the UK, and Clinical Pathology Accreditation or College of American Pathologists approval (specific to the laboratory). These awards are voluntarily gained to demonstrate the depth of knowledge and level of quality throughout the organisation.

Unlike the full service CRO, not many central laboratory services are fortunate enough to have the support of an internal quality assurance (QA) team whose responsibilities are focused on ensuring consistency with quality standards at all times. It is the ability to refer to the on site QA team which enables these types of organisations to really excel within this area and gain awards which at times may be an influencing factor on the success of gaining a contract.

A central laboratory service is not only exposed to audits as part of accreditation renewals. As part of an early phase CRO, the laboratory department will also be inspected each time a sponsor conducts a site visit; these can be frequent occurrences (often weekly) for a successful business. This is also true for any work the laboratory conducts as a stand alone service provider; therefore there are three different occasions in which a laboratory service will be audited. This further demonstrates how using specialist services, such as a central laboratory service based within a Phase I facility, more than often has a higher degree of quality than their stand alone competitors.

LOGISTICS MANAGEMENT

As mentioned, advancements in science have resulted in stand alone central laboratory services outsourcing further analyses to specialist providers to enable them to provide a single solution service. This may be linked by a harmonised data management system, but the samples will still have to be transported to the outsourcing laboratory for analysis.

Maintaining sample integrity is of the utmost importance when providing supporting analysis services during a clinical trial. From the provision of the sample collection kit, through to the collection itself and transport of the sample to the laboratory, the supplier will be responsible for ensuring all conditions are controlled to prevent deterioration. This must be managed effectively to ensure compliance with the tight timeframes specified within the study protocol – a task that is not as straightforward as it may seem. Areas such as shipping regulations need to be considered, in addition to the effects of the increase in complexity of trials which has led to a rise in esoteric testing, thus resulting in complex changes to sample shipping conditions. These can vary depending on the region of transport and the testing required; therefore dedicated personnel with strong expertise in this area are essential.

It has been suggested widely that stand alone central laboratory services have superior logistics management in comparison to the full-service CRO, as the combination of different laboratories collaborating to provide a complete service also means a combination of logistical expertise (1). Although this may have advantages with regards to negotiating lower tariffs and extended knowledge of shipping regulations, involving a number of suppliers to fulfil one service may lead to dilution of the overall service.

Central laboratory services operating within Phase I units have extensive experience of managing complex sample shipments both regionally and internationally. Remaining competitive with the stand alone provider, the Phase I central laboratory service has dedicated courier networks ensuring global coverage for the prompt handling of samples. This is fully managed on site by dedicated staff experienced in managing logistics on behalf of all areas of the business – for example clinic, pathology laboratory or bioanalytical laboratory. Consultation with other laboratory services to access additional logistical expertise is not required, thus reducing the time taken to arrange sample transportation, in addition to removing the possibility for confusion regarding responsibility.

EXPERTISE

As a supporting service to an in-house clinical facility, it is essential that the central laboratory service remains abreast of any scientific developments to ensure they are able to support any new testing requirements received by a sponsor, while remaining compliant with GCP principles. With an observed increase in trial complexity, the requirement for added expertise has risen dramatically, highlighting the importance of being able to offer the latest advancements in testing.

The ability to provide specialist testing services internally may influence decision-makers thus justifying the reasoning behind bringing such testing in-house. An example of this is the request for gamma scintigraphy imaging (see Figure 1, page 58) which when conducted in combination with pharmacokinetic measurements, provides a comprehensive understanding of the effects of the delivery system and dosage form variables on drug bioavailability. It is these types of services which will be frequently outsourced by stand alone providers. This is a benefit to the central laboratory service operating within the Phase I facility, as well as the CRO itself, as it strengthens the company profile and demonstrates full control of quality which will be a winning factor when bidding for work.

The provision of such specialist services requires access to additional expertise which if outsourced will not be directly accessible by the sponsor. This may prove difficult when requiring further interpretation or explanation of results, or if the sponsor requires direct access to the specialist for advice or guidance. Sourcing all services on one site means that in these circumstances, whether using one or all of the services the CRO can offer, there is continual access to additional, specialist expertise.

 Additional on site expertise
  • Scientific/technical knowledge
  • Medical staff
  • Principal investigator
  • QP and pharmacist
  • Data managers
  • Statisticians
  • PMs
  • Recruitment
  • Ophthalmology expertise
  • Logistics management
  • Expert analysts
  • Assay development and validation
  • Dermatology expertise

COMMUNICATION IS THE KEY

A successful working relationship between a sponsor and the service provider is dependent on the level of communication employed. Strong communication is a vital tool and requires commitment from both the sponsor and project manager (PM) for the CRO in order to make the relationship a success.

Tracking the progress of the trial when using multiple providers can become time-consuming and, on occasion, cause confusion. This is not helped when the suppliers do not communicate directly with each other as this puts more responsibility back on the sponsor to manage the project. Frequent occurrences such as exceeding timelines, which are not ideal but can be dealt with confidently and effectively by a single provider, become a larger problem. A single hold-up may result in a knock-on effect down the supplier chain, which, as a consequence, may extend the length of the trial; and as time equals money, this becomes an increased cost for the sponsor.

The full service provider largely removes these communication issues as one site means one consistent approach. The on site PM, supported by the project management team, will nurse a study from start to finish, ensuring timelines are met, progress reports are provided, and all important information is relayed back to the sponsor providing a seamless service. This is demonstrated throughout all areas of the trial from the design of the CRF through to the production of the final report. Employing these services from one centralised provider means that amendments to areas such as protocols, procedures or even reports can be facilitated where necessary to provide the sponsor with a service specific to fulfilling their requirements.

So how is this reflected in the provision of central laboratory services? The experience gained from supporting in-house trials, managed by multi-talented PMs is echoed throughout all areas of the company. This enables the central laboratory to support later phase trials as the leadership skills and key values, such as strong communication, demonstrated in-house by the PMs is passed on to the laboratory staff.

COMMITMENT TO DATA QUALITY

With the ability to integrate specialist testing with routine safety screening, the Phase I central laboratory is able to reduce the number of shipments required and therefore the cost to the sponsor. The increase in testing does require additional data management expertise which can be facilitated easily by the full service provider who has access to data managers and statisticians on site. It has been reported that in recent years the requirement for electronic data services has increased dramatically and that the stand alone central laboratory provider now offers a more efficient, improved data quality service (2). This has been the case within the Phase I facility for many years, ensuring the prompt reporting and sharing of data amongst departments in order to accelerate the trial to the next stage. The support from an on site data management team is also an added advantage, assisting the laboratory with arrangement of data when supporting later phase trials.

EMERGENCE OF THE ENHANCED SOLUTION

As the market adapts to the increase in trial complexity, partnerships have formed between CROs and specialist providers to offer a ‘single solution service’. What has emerged is a full service provider with the ability to provide this ‘single solution’ from one site.

Additional specialist or supporting services such as quality assurance, project management, data management, bioanalytical services and pharmacy services, are situated on site, therefore when supporting later phase trials the laboratory will already have extensive experience communicating with these different departments. These communication skills can be transferred across when operating a stand alone service and collaborating with external providers of these services to contribute to the progression of a trial.

Standards of service are not diluted, which often occurs when using third party suppliers, and the commitment to the continual renewal of skills, expertise and updated methodology demonstrates how using central laboratory services within this facility has many added benefits. Whether conducting a study on site or whether using the central laboratory as a stand alone service, the sponsor can be confident knowing that these skills are constantly in-use, operating to the highest of industry standards.

References

  1. Chennells J and Leroy L, Central Testing, Next Generation Pharmaceutical 5, 2008, http://www.ngpharma.eu.com/article/Central-testing
  2. Logan E, Testing Times, International Clinical Trials: pp72-77, August 2010

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Samantha James is the Business Development Executive for the central laboratory division within Simbec Research Ltd. She holds a BSc in Biology and Forensic Science, and a Professional Diploma with the Chartered Institute of Marketing. Samantha has a laboratory background, having previously held the positions of Project Manager for Synergy Health Laboratory Services and, prior to that, as an analyst with Johnson and Johnson.
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