Welcome
FORENAP, an international Contract Research Organisation (CRO), provides you a wide range of services for the early steps of development of your compounds.
Company overview
Located in Alsace, in the heart of Europe, Forenap Pharma is an International Contract Research Organization (CRO) combined with a “Site Management Organisation” (SMO) specialised in early Drug Development and Research in Neuroscience. Founded in 1986, FORENAP has succeeded in developing in the past 20 years a unique expertise in Central Nervous System. It currently employs 180 people.
Thanks to its shareholder, the Fondation Transplantation, a non profit organisation, FORENAP makes use of public research network.
FORENAP Group is made of two main lines of skills :
- FORENAP Pharma : preclinical and clinical studies management as well as related business activities;
- FORENAP FRP : dedicated to scientific research.
FORENAP proposes optimised development plans and ensures the management of preclinical, Phase I (in all therapeutic areas) and Phase II (for Central Nervous System and Cardiovascular compounds) studies. With its own 72-bed centre, FORENAP conducts :
- Standard clinical pharmacology studies
"First in man", repeated doses, pharmacokinetics, bioavailability, food and drug interactions... - Specific populations studies
Poor metabolisers, insomniac, post-menopausal, obese, elderly... - Proof of concept" studies
Phamacodynamic, human models, central nervous system (CNS), cardiovascular system... - Patients studies
FORENAP offers a “full services package” ( including “consulting” services) to bring your projects to success, from Drug Discovery to Marketing authorization.
Useful features
Stunning visuals
State-of-the-art technology
High-quality images
Clinical development strenghts
- 20 years of experience
- Unique expertise in Central Nervous System
- Adaptability and flexibility
- Quality assurance and control
- State-of-the-art technical platform
FORENAP has been involved in clinical research for 20 years, and has acquired along these years a unique expertise in psychotropic drugs development. FORENAP has performed hundreds of studies, in which over a hundred of central nervous system drugs were tested. Thanks to this experience, FORENAP is one of the world’s leaders in early clinical development.
The 180 employees working at FORENAP and the 72 –bed clinical pharmacological centre (6000 m²) built especially to improve the conduct of clinical studies, allow a great flexibility and enable us to meet the highest requirements. FORENAP activity based on a 23 300 volunteers database optimises the recruitment quality and duration. A high tech technical platform including EEG, MEG, MRI, polysomnography, driving simulator and pupillometry is available to assess at an early stage the effects of a compound on the central nervous system.
Moreover, several human models of pathologies have been implemented at FORENAP, and allow in particular to validate the therapeutic indication of the compound (proof of concept).
FORENAP is one of the only CRO specialised in neurosciences in the world
to be a World Health Organisation (WHO) collaborator.
Scientific research strenghts
FORENAP has developed a wide expertise in the development of compounds acting on Central Nervous System. Our state-of-the-art technical platform as well as our experts’ dynamism allowed us to develop tools to assess the pharmacodynamic effetcs of compounds from first-in-man studies.
In addition of its trials and service provider activities, FORENAP is involved in several projects of collaboration with local and international laboratories, and takes part in European projects. This reinforces FORENAP’s scientific skills and increases the expertise offered to pharmaceutical companies.
Our collaborations
 | The United Nations agency specialised in health; its objective, as set out in its Constitution, is to attain the highest possible level of health for all the people. Since 1997, FORENAP has been a WHO collaborating research centre in neuroscience and neuropharmacology |
| NEUREX is the most important european network in the field of neuroscience |
| The IFR associates 11 Research Units working on CNS topics. These units develop scientific collaborations, and create technological platforms to make Research progress. |
Collaboration with the Center of Epileptology of the University of Freibourg im Breisgau concerning the neuro-pathophysiological phenomena which precede an epileptic fit. |
| Forenap's associate for the clinical trials requiring a PET Scan expertise. |
Institute of Radiolopharmacy lof Tübingen
| Forenap's associate for the clinical trials requiring a PET Scan expertise. |
| Thanks to Fondation Transplantation, FORENAP makes use of a public research network. The foundation proposes its state -of-the-art equipment. |
| Cognitive Drug Research (CDR) is the leading provider of innovative cognitive function assessment technology and services to the pharmaceutical industry |
Our services to companies
FORENAP, your Key-partner
FORENAP Pharma manages the development of your compounds from preclinical to phase II studies. FORENAP Pharma offers preclinical and clinical development plans, a partner’s network for preclinical studies, and its own 72-bed centre for phase I studies. For phase II studies, FORENAP Pharma can act as an investigator centre or a coordinator centre thanks to its investigator’s network in France and in several European countries.
FORENAP Pharma can take care of the overall development of your compound :
- Investigator’s brochure writing
- Protocol design
- Legal authorities submission
- Pharmaceutical development
- Realization of clinical part
- Subjects recruitment
- Monitoring
- Data management
- Biostatistics
- Report writing of trials
For bioclinical studies, the technical platform is one of FORENAP Pharma’s major asset: it offers among other tools wake EEG, polysomnography, magnetic resonance imaging (MRI), magnetoencephalography (MEG), driving simulator, neurocognitive tests…
Clinical development
Rely on FORENAP for your drug development
- 20 years of experience
- 450 studies already performed
- 110 Central Nervous System compounds tested
- FORENAP Pharma and Proof of Concept Strategy
- FORENAP Pharma and human models
- 72 beds available (6000 m2)
- State-of-the-art technical platform
- Participation of 23 300 healthy volunteers (including 8 000 subjects from specific populations)
- Participation of FORENAP FRP, research and development company
Preclinics
The research-based pharmaceutical industry has faced growing challenges in recent years as a result of increased economic and regulatory pressures leading to a need of accelerating drug discovery and development processes.
A good management of preclinical studies will allow to shorten development timelines and to obtain earlier clinical data for your lead candidate.
By combining its expertise in both preclinical and clinical studies, Forenap Pharma will optimise the preclinical/clinical interface in order to initiate Phase I studies in the best conditions.
Our way to manage preclinical studies and our capabilities to anticipate clinical trials will provide you a flow of information throughout the preclinical development and will speed up the coming of your drug to the later stage of its clinical development in the best conditions.
To speed-up preclinical development
- One single partner from discovery to clinical program
Screening and exploratory studies (Central Nervous System)
API synthesis
Safety Pharmacology
Toxicology
Genotoxicity
Metabolism
Analytics
IMPs
Submission documents (IMPD, IB…)
- Direct access to a well set-up international network of experts in preclinical and clinical development
- A broad network of partners has been set up and covers all areas needed for a full non-clinical development of your compound. A good insight of this network allows us to use the skills of each partner at their best.
Preclinical development optimization
- Development of individual and integrated solutions
- Proposal of preclinical and/or clinical development plans (studies design, planning and quotations)
- Set-up and follow-up of preclinical studies
- Review of the preclinical data, required for human trials initiation
- Anticipation to prepare submission documents for clinical purpose (IMPD, IB…)
Human Models
Various models of human pathologies have been implemented at FORENAP. These models allow us to assess the pharmacodynamic effect of a molecule on healthy volunteers, to confirm the therapeutic indication and to determine the potential effective doses which will be assessed in patients studies. We can therefore assess the potential of a compound from its initial stage and thus avoid a late failure. The development cost is optimised.
INDICATIONS | MODELS |
| Alzheimer disease / Cognition | Scopolamine Lorazepam Non-pharmacological |
| Depression | Tryptophan depletion |
Anxiety | CCK-4 Classical conditioning |
| Schizophrenia | Apomorphine Ketamine |
| Pain | Thermal Stimulation Pressure Capsaicin |
| Ischemia | Hyperventilation |