Biotech company Ablynx wins European Mediscience Award: http://tiny.cc/knen6
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Website: http://www.harrisonclinical.com
Phone: +32 2 469 39 71
FlandersBio Member
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For 21 years, the international contract clinical research organisation (CRO), the Harrison Clinical Research Group has been providing its clients with a complete range of flexible contract clinical research services, both locally and globally.
We all want to shop where you can get everything you need in one place and where you do not have to read a lot of labels as you trust the product to be ethically and organically viable and you know you are getting quality.
In clinical research terms, this is the Harrison Effect or Harrison Style. Harrison Clinical Research is the name you associate with clinical research services based on quality, good practices, ethical considerations, good client communication and customer satisfaction.
We are the best solution for your clinical development needs.
Harrison globalises and localises - deriving benefits from the intersections between global activities and local know-how.
Harrison standardises and innovates, endeavouring to prevent consistency from becoming stifling conformity.
Harrison not only fosters a common universal culture but also respects individual differences, seeking inclusion and diversity.
Dr. Francisco Harrison, an Anglo-Spanish physician who completed post-graduate medical studies in Munich before holding several medical management positions in the CRO and Pharmaceutical industries, founded Harrison Clinical Research in 1987. It remains today a privately owned company.
Since 1987, we have established offices in the UK (1992), Benelux (1996), Israel (1998), Spain and France (2000), Italy (2002), Austria, serving Eastern Europe (2004) as well as in Russia, Ukraine, Poland (2007) and USA (HCRAmerica, 2008). All our offices offer complete monitoring of clinical studies from Phase II-IV and local consultancy.
Over the years our Munich headquarters has expanded and houses one of our two Phase I clinics and our Clinic for Nutritional Medicine, as well as International Clinical Operations, Data Management and Statistics, Quality Assurance and Auditing, Medical Writing and Pharmacogenetic consultancy. We have a second Phase I clinic in Tel-Aviv, Israel, our Regulatory Affairs department operates out of the UK and we have an affiliate training company in Belgium. We are also able to arrange EU representation for those companies operating outside of the EU and have a range of IMP services. We can also offer clients diagnostic imaging for oncology studies.
We were awarded the ISO 9001:2000 certification in 1998 for quality management and have an unusually low staff turnover of less than 5%, many of our key staff having been with the company since its earliest history.
We have entered strategic alliances with a US CRO, a Japaneses CRO and a Canadian CRO and we have partners in Scandinavia, Canada, Brazil, Argentina, Mexico, South Africa, Poland, Russia, Bulgaria, India and Australia.
Our services vary according to your needs and we will always offer you a tailor made solution. All projects are supported by an HCR study physician, ensuring continuous review of safety, ethical and clinical aspects and quick response and turn-around of medical issues.
Harrison Clinical Research 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.
Harrison Clinical Research has two clinical units, one in Munich with 18 beds for long-term stay over several weeks and a maximum of 36 beds for one or two overnight stays, and the other in Tel-Aviv with 27 beds. Both units perform state-of-the-art services in Phase I -IIa from first administration in man, pharmacokinetic/pharmacodynamics and bioequivalence studies.
EU regulation EC 1924/2006 regulating health claims, requires scientific proof of efficacy before nutritional product manufacturers can claim specific health benefits, such as functional and novel foods, food supplements or foods for particular nutritional purposes. In our Clinic for Nutritional Medicine, we can supply all the clinical research services necessary with either healthy volunteers or special patient populations. We have considerable experience with nutraceutical or food studies in large study populations with complex study product supply and logistics and the clinic has proven to be very flexible meeting the challenges presented by e.g. cultural differences. The clinic can handle studies of over 1000 subjects and can screen up to 200 patients/day in fully equipped rooms separate from our Phase I clinic and with its own entrance/exit from the street. Our ISO 9001:2000 certification was extended in April 2007, to include quality management recognition for studies for the food industry.
Our core competence includes:
- Study set-up, assistance with contract negotiations, investigator recruitment, pre-study qualification visits
- Protocol writing and review
- CRF/eCRF development and/or review
- Ensuring subject safety and regulatory compliance in IRB affairs
- Training study site teams in protocol and study management
- Performing initiation visit, monitoring visits and study close-out visit
- Managing study supplies and clinical site payments
- Expediting accurate, clean and supportable study data
- Ensuring complete collection and archiving of all regulatory and study data
- Ensuring audits and QA review carried out by QA unit
Whether you require immediate assistance with a specific task, or professional advice and help with an entire project our commitment to quality and customer service is guaranteed. From protocol to final study report - we can manage your clinical trial. Our Data management group offers more than 15 years experience in a broad range of therapeutic areas.
Our auditing team is part of the Quality Management Group and has gained a vast amount of experience by conducting audits for over 500 studies in more than 20 countries, since 1996. We provide a full range of services, including the preparation, conduct, documentation and follow-up and certification of site and system audits. Audits can also be performed in teams together with co-auditors from the Sponsor
Harrison Outsourcing allows you to increase your clinical research personnel at intensive times in your project, enabling you to insource our monitors, project managers, clinical research nurses and /or study site coordinators on an ad hoc or short term basis, allowing peak moments in clinical research to be easily managed.
Via our facility the European Centre for Clinical Research Training (ECCRT), situated in Brussels, Belgium, we offer extensive training courses tailor made for your clinical research personnel. Courses are divided into modules ranging from introduction to monitoring to regulation of clinical studies, statistical issues and project management. These courses are given in several languages and adapted to the needs of each participant or organisation. The ECCRT was awarded the ISO 9001:2000 certification on 1. April 2004, for the:
Provision of clinical research and associated training courses.
For further details click on: www.ECCRT.com
Harrison Clinical Research has an international scientific advisory board comprised of established specialists from different countries and different medical areas. This ensures that clinical studies are performed according to the latest medical thinking and that the best approach to obtaining marketing approval is made.
The Benelux office of Harrison Clinical Research is licensed by the Belgian authorities to import, export, store and distribute IMP. This centralised position is ideal for distribution of study medication throughout Europe, significantly reducing customs delays, improving the regulatory permit processes and allowing strict time lines for supply and re-supply to be met.
Transportation to and from our depot is performed by courier companies certified for this purpose, assuring precise tracking and controlling of the IMP from warehouse to the investigational site and back. The following services are available: IMP storage, distribution, accountability and destruction, QP Release of IMP to European Countries
Our Medical Writing team is integrated into our global team of experienced data managers and statisticians, scientists, physicians, clinical pharmacologists and qualified personnel in pharmacovigilance, registration and regulatory affairs.
We can help in the preparation of:
All medical writers are qualified in medicine or the life sciences and are members of the European Medical Writers Association. All documents are peer reviewed and undergo formal quality control before release.
Asklep Inc. and HCR announced a non-exclusive collaboration in June 2006, to meet the growing global needs of their pharmaceutical clients, by increasing the clinical capabilities and services of each, with the expanded geographical coverage.
Asklep Inc. was founded in 1992, in Tokyo and is a full service CRO and part of the INTAGE group of companies. INTAGE INC. is the largest marketing research company in Japan and the twelfth largest globally. It has one of the most comprehensive healthcare solution services in the industry.
Over the last year both of us have gained extensive knowledge and understanding of each others company, regarding organisation, business philosophy, operating principles, personnel and general and specific strengths, allowing each to offer clients a global service with local market expertise.
www.Asklep.co.jp
Since 2006, HCR and CTI have a non-exclusive agreement to expand the clinical trial services of each company into each others markets, to better serve clients at all stages of drug, device and market development...
CTI chose HCR from almost 100 CROs in order to provide clients with the same high quality service on a global basis and to meet the needs of the changing pharmaceutical industry. CTI felt that HCR had a philosophy similar to its own regarding excellent customer service and a strong reputation for quality.
CTI has been a full service CRO for over 20 years and has the ability to incorporate both clinical and market driven endpoints and interpretations into their programmes. In CTI, we at HCR, have found a CRO which mirrors our own ideals and which has allowed an untroubled evolution and transposition of project capabilities with regard to quality, client communication and customer satisfaction.
www.CTIfacts.com
ASKA and HCR have been working together for several years in Canada, North America and Europe. In 2008, both companies signed a non-exclusive strategic alliance agreement to expand the global reach of both companies, thereby optimising services to their clients in all aspects of global drug and medical device development, education services and clinical trial management.
The formalisation of a six year long relationship with ASKA provides HCR access to a pool of qualified and experienced monitoring staff located throughout Canada and within the USA. This provides our European based clients the opportunity to expand clinical trials into Canada and the USA and have them managed and monitored by local professional staff possessing strong relationships with North American sites and investigators. The regionally based management increases the efficacy of clinical trials, including potential for improved risk management, enhanced enrollment and cost effective monitoring.
ASKA's core competencies of clinical trial monitoring and management services are client focused and committed to strategic growth . They offer responsive services including clinical development planning , monitoring for all phases of clinical trials involving pharmaceuticals , biotechnology products, biologics and medical devices, project management, regulatory support ,quality assurance, clinical trial auditing and SOPs. ASKA also maintains and manages an extensive network of experienced clinical research professionals located in major urban centres across Canada and the USA. In addition, ASKA offers professional development in clinical quality related areas through the provision of customised company specific or general training to companies worldwide.
www.ASKAresearch.com
Partners and Associates
Our valued friendships
As well as our own offices in Germany, UK, Belgium, Israel, Spain, Italy, France, Austria, Russia, Ukraine, Poland, USA and Japan and our 2 Phase I clinics in Munich and Tel-Aviv, we value the following associations:
Asklep Inc. and HCR announced a non-exclusive collaboration in June 2006, to meet the growing global needs of their pharmaceutical clients, by increasing the clinical capabilities and services of each, with the expanded geographical coverage
Address:
Keizer Karellaan 576
1082
Brussels
Belgium
Route: Via Google Maps
Website: http://www.harrisonclinical.com
Phone: +32 2 469 39 71
Fax: +32 2 465 56 23
Foundation date: 1987
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