Alofisel® (formerly Cx601 / darvadstrocel) is the first allogeneic stem cell therapy to be approved for the treatment of complex perianal fistulas in adult patients with Crohn’s disease.
Acumen provides clinical research and development services to pharmaceutical, biotechnology and medical device clients worldwide, supporting our clients in their drug discovery and development work.
Independently owned, our expertise supports the full spectrum of contract clinical research – from pre-clinical to phase I-III studies.
Backed by extensive expertise to support regulatory filings, drug safety and QA, our accredited laboratories provide dedicated clinical pathology, microbiology and bio-analytical services. And our 24-bed trials facility located in Greater Manchester UK accesses a large and diverse patient and volunteer population.
Focused on clinical success, we are committed to our clients’ safe, efficient and successful drug development.
Pre-clinical and Phase I/IIa studies
- Proof of concept
- First administration to man
- Pharmacokinetics and pharmacodynamics
- Safety and tolerance
- Toxicology and ADME
- Special patient populations including type I/II diabetes, asthma, hypertension, cardiovascular disease, obesity and dermatological conditions
- Extensive patient and volunteer database backed by rapid identification and selection
- Specialist studies including euglycaemic clamp, pain, absorption, skin assessments, asthma, renal, elderly impairment, photodynamic therapy
Early phase clinical development is our core strength, with every step in the process handled by professionals. We ensure your early stage trial is safely and correctly designed, right from the start.
Our teams of physicians, research nurses and project managers help to ensure our enviable reputation for successful completion of studies.
Our quality and speed of service, understanding of client needs and open honest communications sets us apart. We add significant value to your clinical research projects, and your return on investment is our priority.
Phase IIb/III/IV studies
- Fast-track patient recruitment for late stage marketing trials
- Special patient populations easily accessible and rapidly recruited
- Trusted network of General Practitioners and hospital consultants
- Dedicated project management for each study
- 24-bed fully accredited facility – ideal for short and longer stays
A phase I 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 recruited and project timelines were met.
The client made a timely ‘go-no go’ decision, saving time and money. Acumen saved a failing study, responding rapidly to client needs.
Enjoy peace of mind – our expertise and efficiency delivers RoI for every client, every time. Regulatory services
- Drug safety and pharmacovigiliance
- Regulatory filing, advice and guidance
- Biometrics and data management
- Protocol and case report design
- Report creation and medical writing
- Quality assurance
- Fully accredited laboratory (GLP, CPA, ISO9002, UKAS Quality Management registration)
- Trusted partners enable us to access pre-clinical toxicology, rapid bio-analytical techniques, validated bio-markers, bio-discovery and sample logistics
As the Acumen corporate website is currently going through an update, please use the contact details below for any enquiries.
Abaloparatide-SC is an injectable formulation of abaloparatide developed by Radius Health for the treatment of osteoporosis in post-menopausal women.
Xeljanz XR (tofacitinib citrate) is an 11mg once-daily oral JAK inhibitor developed by Pfizer for the treatment of moderate to severe Rheumatoid Arthritis (RA).
Nuwiq injection is the first recombinant anti-haemophilic factor (blood coagulation factor VIII) drug indicated for the treatment of patients with haemophilia A.
Portrazza (necitumumab) is a recombinant human lgG1 monoclonal antibody developed by Eli Lilly, for the treatment of metastatic squamous non-small cell lung cancer (NSCLC).
Developed by Amgen, Imlygic (talimogene laherparepvec) is the first injectable formulation of altered herpes simplex virus type 1 for the treatment of cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrence after initial surgery.