About our partner


Our Partner can advise you on the best way to carry out your project and work out the best solution for you, with specialised services designed to meet your specific needs in the performance of your study from single studies to complete development programmes. Whether it be Phase I-IIa (in our own clinics), Phase II-IV, Outsourcing, Monitoring, Biostatistics and Data Management, Medical Writing, Auditing or Training. If you have a bio-pharmaceutical product we can also offer you help with Contract Manufacturing, Business Partnering and Resource Funding as well as complete clinical development and reporting.

Our Partner has two clinical units, one in Munich with 18 beds and the other in Tel-Aviv with 27 beds. Both units perform state-of-the-art services in Phase I and IIa studies ranging from first administration to man, to pharmacokinetics/pharmacodynamics and bioequivalence studies. These include single dose and multiple dose studies, steady-state kinetics, interaction studies (drug-drug, drug-food and other interactions), special populations "proof of concept studies" in patient volunteers (elderly, renal and hepatic failure, diabetes, hyperlipidaemia, hypertension and others) that involve extended in-house periods. Studies are carried out strictly in compliance with ICH-GCP requirements.

Phase I studies are performed using various routes of administration and offer validated pharmacodynamic models for cardiovascular, CNS and other therapeutic areas. In both units, the studies are performed within an optimal environment assuring the maximum safety of the volunteers and includes both GCP monitoring as well as experienced medical evaluation.

The GCP partner has specialised staff in diverse therapeutic areas as well as a scientific board that allows them to plan and design studies for a wide range of indications. They also have substantial expertise in studies using medical devices and diagnostic kits.They provide a full service in the designing, managing, monitoring and reporting of Phase II-IV clinical studies and has a wide network of experienced monitors worldwide. They have specialised staff in diverse therapeutic areas as well as a scientific board that allows us to plan and design studies for a wide range of indications and we have substantial experience using medical devices and diagnostic kits.

Our Partner is, therefore, able to work internationally in a variety of countries with key investigators and opinion leaders on a global basis. They can thus offer you direct access to research activities in the world's key markets with the same high standard of quality and GCP but without the administrative complexity often associated with much larger companies.Our Data management group offers more than 15 years experience in a broad range of therapeutic areas and services including:
Our Quality Management/Auditing team has gained vast experience by auditing all studies carried out since 1996, which means that at least 500 studies have been audited by us. Internal (QM system) and external (contracted from our sponsors) audits follow the standards of ISO 19011 and the ENGAGE Optional Guideline for GCP Compliance and Quality Systems Auditing, from the European Network of GCP auditors and other GCP experts.The audit plan for a contracted audit is always peer-reviewed, reflecting that the scope and objectives of the audit are agreed to and the areas to be addressed are known to and accepted by the sponsor, in advance. Audit reports are written within defined timeframes, peer-reviewed, released and distributed in concord. A formal signed communication that all findings have been addressed, is always considered a part of the audit.

For all your studies, we can offer you full service for protocol, patient information/informed consent, CRF, supplier, Trial Master File, on-site, data management and clinical report auditing.

In addition to the audit services, we offer help in setting up and implementing Quality Management Systems in your offices and in the preparation and conduct of system audits.

The programme includes full training capabilities, both internally and externally. They have also published many articles in international journals on related topics and we are present at major related international congresses, often as session chairperson or with a presentation role.