» Accreditation – a laboratory Icon
13 March, 2015
Icon Development Solutions (IDS) specialises in the strategy, management and execution of product development and early phase clinical development. It has expertise in the clinical pharmacology, regulatory affairs, pharmacokinetics, pharmacometrics, biopharmaceutics and bioanalytical sectors. With such a wide range of services on offer, its customer base is similarly broad – from global pharmaceutical companies to small/medium biotechs and academic institutions. One thing that this diverse collection of clients shares is the need for high quality, accurate information.
Accreditation for Accuracy
The primary method that IDS Clinical Pathology Laboratory has employed to ensure it can deliver confidence in its results is to become accredited by the United Kingdom Accreditation Service (UKAS). Bimal Sethi, Laboratory Manager for IDS said “Achieving accredited status ensures that the business moves in a consistent manner and that quality is uppermost. In a highly regulated industry such as ours, accreditation is an objective measure of quality which conforms to the required global standard. Thus, it enables us to work for institutions that are mandated to both perform and evidence their data to specified standards, such as the FDA & EU directives. Being accredited gives our customers the confidence that we are delivering high quality, accurate results.”
IDS currently holds UKAS accredited certification for the ISO9001 quality standard, as well as the ISO17025 standard for the competence of testing and calibration laboratories. Sethi said. “It is all too easy for companies operating in our industry to forget that a laboratory is also a business. Therefore we have chosen to split the accreditation into the general quality side and the testing laboratory specific side. This allows us to look at maintaining quality from both a business as well as a more technical point of view.”
IDS is a sub-division of Icon Clinical PLC, a NASDAQ quoted company. Icon Clinical has some 6,000 employees operating from 60 offices across 30 countries. IDS accounts for 300 of those employees, working from 5 offices, one of which is based in Manchester. Being a truly global company, the international reach of accreditation has been of particular benefit to IDS, as Sethi explains. “UKAS is a signatory to the relevant international Multi-Lateral Agreements (MLAs), meaning that UKAS accreditation is recognised across the world. This makes it much easier for us to attract clients that are either based or have work overseas. Where a set of clinical trials is happening in several different countries, we need to know that the quality is the same. The MLAs help us to maintain consistency and avoid surprises.”
Accreditation can also help a laboratory to become more efficient, by allowing it to re-examine and streamline existing working methods. “The process of becoming accredited meant that we had to take a close look at our own business practices. This enabled us to identify areas for improvement and implement changes, allowing us to make sure that we are applying best industry practices and keeping pace with technical developments. It is a valid tool for ensuring that we maintain high levels of data integrity and quality of output from the laboratory. This in turn reduces the amount of data which requires cleansing and speeds up the process of report writing.”
Taking the Pain Away
Renovo is a biopharmaceutical product company, specialising in the discovery and development of drugs to improve the appearance of scars and enhance wound healing. Started in 2000 with just two employees, Renovo has now grown to 180 staff and was floated on the London Stock Exchange in 2006.
Renovo’s leading products are currently in clinical development in both the US and throughout Europe. An accredited testing laboratory forms a crucial part of these trials, as Mark Cooper, Senior VP, Clinical Operations explains. “Pharmaceutical trials are run in a highly regulated environment, and the use of accredited testing procedures is essential for this field of work. The regulatory authorities stringently check that the services we use are properly verified and accredited. We are unable to perform some of the necessary testing procedures at our own in-house clinic, so need to outsource them to an accredited laboratory. Put simply, without employing the services of an accredited laboratory, we would not be able to meet the high standard required for operating in this sector.”
There are other reasons behind Renovo’s choice of an accredited laboratory. Cooper said. “Because Icon Development Solutions is accredited this gives us a higher level of confidence in the services that it provides. We know that IDS follows established procedures that have been independently assessed and verified in accordance with leading industry standards. Consequently, we can rely on the accuracy of the results, which avoids the need for costly retesting and any consequent delays to the development process.”
Sethi echoed these sentiments when he said. “Our accreditation represents a guarantee of the independently verified quality standard and enables a reduced audit process. This translates into subsequent time and cost savings for our customers and provides them with the reassurance that globally consistent processes are being employed.”