Flamek

Services

Clinical trails

The full spectrum of Pre-clinical, Regulatory and Phase I/II Contract Clinical Research Services is covered by FLAMEK. The expertise in these disciplines covers a broad range of therapeutic areas and is provided 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.

FLAMEK is able also to offer a full range of individual or combined services according to the client's wishes, these include:

Pre-clinical and clinical strategic development programmes Regulatory advice and strategies, submissions 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 (General Practitioners and Hospital Consultants), 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 (PICRA) of integrated external clinical research specialists/service providers, allowing access to pre-clinical toxicology, rapid bio-analytical techniques, validated biomarkers, bio-discovery and simple sample logistics.

Providing flexible innovative solutions to expedite the clinical trial process, FLAMEK 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 & commitment to fulfilling the objectives of the clients’ projects.

FLAMEK’s wide-ranging experience ensures that clients receive true added value to their research projects and that these are completed in the speediest and cost effective manner:

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

Not only does FLAMEK have an extensive database of healthy male and female volunteers, but it is 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:

Asthma Anti-infectives Acute postoperative pain Cardiovascular Disease Chronic cancer and non-cancer pain Cognitive impairment Chron’s Disease Dermatological skin conditions Diabetes - Type I/II Elderly Hypertension Obesity Post-menopausal, surgically sterilized/hysterectomised women Renal Impairment

 

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