Acumen Pharmaceutical Services Ltd

Focused on successful safe clinical trials

Innovative and flexible early-phase clinical development services, provided by experts, committed to quality and delivery.

Acumen provides contract clinical research and development services to pharmaceutical and biotechnology clients worldwide, supporting drug discovery and development.

Close collaborative relationships with high-quality clinical service providers enables us to provide a seamless, reliable drug development process, and one that is focused on client and sponsor success.

Our team of clinical research professionals, physicians, research nurses and project managers are widely respected and possess years of experience in all aspects of pharmaceutical contract research.

We manage pre-clinical phase I/IIa through to phase IIb-IV trials. Backed by extensive expertise to support regulatory filings, drug safety and quality assurance (QA), our on-site accredited laboratories (GLP-CPA, ISO9002, UKAS QM registration) conduct clinical pathology, microbiology and bio-analytical work for clinical trials.

Located within easy reach of Manchester city centre, motorway networks and Manchester International airport our 24-bed trials facility accesses a large and diverse patient and volunteer population.

Pre-clinical and Phase I/IIa Trials

Early phase clinical development is our core strength, with every step in the process handled by professionals with extensive therapeutic expertise. We ensure that your early stage clinical trial is safely and correctly designed, right from the start.

From the quality of advice you'll receive, to a genuine understanding of your study requirements, and with our commitment to fulfilling your study objectives, Acumen delivers.

Your clinical trial is supported by our on-site accredited laboratories and a team of experienced consultants including general practitioners, physicians and research nurses.

Acumen's support for pre-clinical and phase I/IIa trials includes:

• Proof of concept
• First administration to man
• Pharmacokinetics and pharmacodynamics
• Safety and tolerance testing
• Toxicology and ADME screening
• Special patient populations database including type I/II diabetes, asthma, hypertension, cardiovascular disease, obesity and dermatological conditions
• Extensive volunteer database and rapid patient identification and selection
• Specialist studies including euglycaemic clamp, pain, absorption, skin assessments, asthma, renal, elderly impairment, photodynamic therapy

Phase IIb/III/IV Trials

Enjoy peace of mind - our expertise and efficiency delivers RoI for every client, every time. With a dedicated and expert project manager for each study, your clinical trial is efficiently and professionally managed, with clear and consistent accountability for project milestones.

A phase I clinical trial initiated in another CRO was lagging after 24 months with only 25% of patients recruited. When Acumen agreed to join the study as another centre, all patients were rapidly recruited and project timelines were met. The client made a timely 'go-no go' decision, saving time and money. We saved a failing study by responding rapidly to sponsor needs and provided effective volunteer recruitment.

Acumen can take a range of roles in phase IIb/III/IV Trials including:

• Fast-track patient and volunteer recruitment for late stage marketing trials
• Trusted network of General Practitioners and hospital consultants
• Dedicated project management
• 24-bed fully accredited facility
• Stand-alone site or part of a multi-centre trial

Patient and Volunteer Recruitment

Acumen are experienced in patient and volunteer recruitment. We hold an extensive and up-to-date database of healthy male and female volunteers, but we are also increasingly recognised for our successful recruitment of special patient groups.

We'll fast-track the selection, screening and recruitment of special patient populations for small or large phase II clinical studies, and we've already done this for a diverse range of studies in:

• Asthma
• Anti-infectives
• Cardiovascular disease
• Cognitive impairment
• Chron's disease
• Dermatological skin conditions
• Diabetes (type I and II)
• Elderly
• Hypertension
• Obesity
• Renal impairment
• Women (post-menopausal, post-hysterectomy)

Regulatory Services

Our regulatory services professionals help you to strategically plan for authorisation and licensing, either as an independent service or integrated into sponsor teams.

• Drug safety and pharmacovigiliance services
• Regulatory filing, advice and guidance
• Biometrics and data management
• Report creation and medical writing
• Quality Assurance

You'll want a contract research organisation (CRO) with extensive therapeutic expertise, a proven track record in conducting clinical trials quickly without compromising on quality, and that ensures full communication at every stage of a study.

Contact us and we'll provide an expert and competitive proposal, focused on clinical success.