Acumen - Pre-Clinical, Regulatory and Phase I/III Contract Clinical Research Services

Acumen is dedicated to the early development of medicines and has a rapidly growing reputation as an innovative phase I/III contract research organisation. An extensive range of expertise and specialist services is provided across the full spectrum of pre-clinical, regulatory and phase I/III contract clinical research services and a broad range of therapeutic disciplines to the pharmaceutical and biotechnology industries to complement their in-house expertise and support the relevant area of the drug discovery process. The high quality, flexible and fully integrated clinical development services have been developed to assist clients with accelerated start up and rapid development of their drug development lifecycle.

CLINICAL FACILITIES - CLINICAL PATHOLOGY AND BIOANALYTICAL LABORATORIES

Acumen is a team of fully trained, dynamic and flexible clinical research professionals, physicians, research nurses and project managers with a strong work ethic, who are widely respected and experienced in all aspects of pharmaceutical contract research. The clinical research unit provides excellent facilities for both short and long-term residence; this together with our careful screening selection procedures ensures that we have an enviable reputation for patient and healthy volunteers successfully completing studies.

Acumen has on-site clinical pathology and bioanalytical laboratories, which are fully accredited (GLP statement of compliance, CPA Accreditation, ISO9002, UKAS Quality Management Registration) with facilities for on-line link-up to any location.

CLINICAL SERVICES

Acumen provides a full range of high quality individual or combined services according to the client's wishes, these include:

• Pre-clinical and clinical strategic development programmes
• Regulatory advice and strategies
• Protocol and case report form design
• Extensive database of healthy volunteer and patient populations
• Rapid patient identification/selection and recruitment, aided by an extensive collaborative network of local physicians, providing excellent opportunities for accelerated start-up of phase II studies in 'special patient population groups'
• Project management
• Data-entry and data-management
• Clinical Pathology
• Safety monitoring/pharmacovigilance
• Pharmacology, pharmacokinetics
• Statistical analysis
• Clinical report and manuscript writing
• Quality assurance
• Extensive collaborative alliance network of integrated external clinical research specialists/service providers, allowing access to pre-clinical toxicology, rapid bioanalytical techniques, validated biomarkers, bio-discovery and simple sample logistics

EARLY PHASE CLINICAL DEVELOPMENT CONTRACT SERVICES

Providing flexible innovative solutions to expedite the clinical trial process, Acumen distinguishes itself from other 'early phase clinical development contract services' by the quality of the advice we deliver, our understanding of the client's needs and our communication and commitment to fulfilling the objectives of the client's projects.

Our wide-ranging experience ensures that our clients receive true added value to their research projects and that these are completed in the most speedily and cost effective manner.

CLINICAL STUDIES

Acumen's early phase clinical development expertise extends across a broad range of clinical studies:

• First into Man
• Phase I safety and tolerability studies
• Human ADME studies
• Interaction studies
• Safety and efficacy studies
• Proof of concept studies
• Specialist studies, e.g. euglycaemic clamp, pain models, absorption studies, skin assessments, photodynamic therapy, asthma models, elderly kinetics, renal impairment, etc

SMALL AND LARGE PHASE IIA CLINICAL STUDIES

Not only does Acumen have an extensive database of healthy male and female volunteers, but it increasingly acknowledged as having significantly large and extensive 'special patient population groups'. A key and continuously expanding service provided by Acumen is the fast-track selection and recruitment of large database 'special patient population groups' for the conduct of both small and large phase IIa clinical studies, for example:

• Type I/II diabetes
• Asthma
• Post-menopausal, surgically sterilized/hysterectomised women
• Hypertension
• Cardiovascular disease
• Chron's disease
• Obesity
• Renal impairment
• Elderly
• Dermatological skin conditions

Acumen has also actively recruited patients for multicentre phase III clinical trials, acting as a central site and often aided in the rapid recruitment/conduct of patient studies in collaboration with other larger contract research organisations.

CUSTOMER SERVICE

If you require a CRO with broad therapeutic experience that will set up, conduct and report clinical trials quickly without compromising quality, that ensures excellent communication with their clients at every stage of the clinical trial process, consider Acumen for a full discussion of your needs and provision of a quote and timeframe to effectively accomplish them.

For further information on the services and areas of therapeutic expertise that Acumen can provide please take a look at our website or contact: