We are leading contributors to the development of industry best practice and are recognised as providers of thought leadership around the use of information technology in regulated industries.

We have developed a comprehensive portfolio of services, covering all sectors within the Life Sciences industry, including pharmaceuticals, biomedical and biotechnology, medical devices and veterinary products.

Our expertise covers business operations in all areas; from discovery, research and development, through clinical trials and manufacturing, marketing, sales and distribution.

Our Unique Skill Set

The strength of our solutions and services is based upon our unique blend of skills and experience:

• Our business and management consulting skills
• Our in-depth regulatory knowledge
• Our understanding of (and contribution to) regulatory guidance and industry leading computer systems validation best practice
• Our knowledge of leading edge information technology applications and technology
• Our partnerships with industry leading suppliers

The following sections highlight our Life Sciences solutions and services and where these add value to our clients.

Project Management

We understand that the hallmark of a good project manager in Life Sciences is the ability to appropriately balance not only timescales and budget but also quality (computer systems validation and regulatory compliance). Our ISO 9001:2000 registered quality management system incorporates a project management methodology mapped against PRINCE 2 and our project managers are not only PRINCE 2 practitioners, but are also fully up-to-date in current regulatory and industry guidance with respect to validation and compliance.

In Life Sciences, our project management services make the difference when it comes to delivering on-time and within budget, but also in compliance with regulatory expectations.

Risk Management

With an increasing focus of risk-based compliance and with increasing focus on managing risk to product quality and patient safety, most Life Sciences organisations are moving towards a risk-based approach to quality management as well as specific tasks such as computer systems validation. With ten years experience in applying risk management techniques in research and development, manufacturing, sales, marketing and distribution, our proven methods for assessing, monitoring and managing risk are based upon GAMP, ISO 14971 and ICH Q9. More importantly, our approach is both pragmatic and cost effective, providing the basis for managing both regulatory and business (operational and financial) risk.

Business Process Modelling

Although there are many tools for mapping business processes, none are designed to recognise the importance of regulatory critical processes. Embedding the need to assess and document risk, cross reference regulatory sub-parts and identify the scope of regulatory significant records and signatures, our techniques and tools support any business process modelling or re-engineering exercise. Having helped define the latest regulatory guidance and industry good practice guides, our methods deliver business process models that are designed to meet the specific needs of the Life Sciences industries and which can be cost effectively maintained by our clients without the use of specialist third party applications.

Vendor / Software Package Selection

Many software or IT projects go wrong at the first stage - by not considering regulatory requirements when selecting software vendors or packages. Supported by auditors specifically trained in auditing software suppliers and developers, our software vendor and software package consultancy services are designed to reduce the risk associated with acquiring a new computerised system. Based upon previous engagement and our knowledge of the industry, we are able to provide a shortlist of vendors experienced in the Life Sciences industry. Our transparent and objective selection process recognises regulatory good practice at all stages, guides clients through the process of selecting the most appropriate solution and focuses on minimising the total cost of compliant ownership.

Requirements Analysis and Development

While complying with industry good practice, traditional User Requirements Specifications often fail to provide a document that is useful for validation purposes, often fail to support requirements traceability and often fail to represent the real needs of the User. By combing requirements analysis best practice and considering the underlying intent of regulatory guidance, we have developed a better way of analysing and documenting requirements for enterprise class applications. By integrating risk impact assessment, identifying critical control points and clearly identifying regulatory scope, the resulting User Requirements are less expensive to verify, easier for clients to maintain, lead to solutions that are demonstrably ‘fit-for-purpose' and most importantly of all, provides greater User satisfaction.

Change Management

When implementing any new computerised system in Life Sciences, the impact upon users must be considered, planned for and addressed. As specialists in the industry we understand the regulatory and business consequences of going live with users who are not appropriately educated, experienced or trained. With services ranging from the review of existing and future user roles, preparation of new or revised user Standard Operating Procedures, preparation and implementation of multi-media communication plans and the provision of computer based and/or on-line learning, we can help ensure that users are ready for the implementation of their new system and are effective from day one.