About Us


Philosophy

Our aim is to provide the best possible CRO services to small and medium-size pharmaceutical sponsors. Our multi-site organization offers consistency and experience, at competitive prices.

We believe that the CNS field, which now comprises 30% of all drug development, represents an unmet need which will continue to grow, as the search for solutions to functional and degenerative brain diseases continues.

TGD is a strategic partner to small and medium-sized pharmaceutical and biotech companies. We conduct phase II,III and IV studies for pharmaceutical companies, studies for academic consortiums and investigator-initiated trials (IITs), sponsored by the European Community, and by US funding agencies and NGOs.

 


From its inception, we realized that in order to compete successfully with existing CROs we must focus on unique expertise, personalized treatment, accuracy, and fast response to sponsors’ demands.These features made us a boutique research center, bringing large and small sponsors back to us again and again.

As a CNS-specialized research organization, TGD’s staff is aware that in the absence of reliable biological markers for diagnosis and treatment outcomes, the sensitivity of our assays cannot be taken for granted. With time we have accumulated experience with electronic CRFs, assessment scales, centralized rater training, patient’s assessment, and the rest of the ancillary methods utilized in multi-center international trials, to improve assay sensitivity. We have also been convinced that no matter what ancillary methods employed, ultimately the success of the trial depends on the proficiency and dedication of the investigators and on the diligence of our staff. We have therefore created a network of capable investigators whom we train and support in their academics endeavors, and they reciprocate by delivering the best possible product for the sponsor.

Our assumptions about the optimal manner to improve assay sensitivity have been validated by our ability to detect cognitive signals in two diverse diagnostic categories (schizophrenia and Parkinson) in placebo/active/control trials and in add-on trials.

TGD intends to adhere to this boutique strategy, and this approach will continue to define our relationship with our customers, regardless of the size or complexity of the project. Sponsors engaging either our end-to-end services or a single service provided in several countries are assigned a global project leader who coordinates all their needs and services across our organization and across territories.

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History

TGD was founded in 2000 by Ilan Gonen, M.D. an oncologist and healthcare manager who still manages it.
He was joined later by Paull Radu, M.D. an internist/geriatrician with 15 years of experience in the clinical trials and pharmaceutical industry.

TGD activities are supported by a scientific advisory board of internationally renowned experts in psychiatry, neurology and neuropsychology, headed by Professor Michael Davidson. The board members conduct in-house training sessions, interact with sponsors, attend investigator meetings, and supervise and re-train investigators during the trials.

Our team includes researchers trained in clinical pharmacology, psychiatry and neurology, neuropsychology and psychometrics. The team also includes researchers trained in pharmacovigilance and regulatory affairs.

In the past seven years TGD has successfully concluded contracts for major pharmaceutical companies as well as several medium-size sponsors. TGD is now the largest CNS-specialized clinical research organization in Romania, operating at 40 academic medical centers and maintaining a network of over 300 of the leading neurologists and psychiatrists in the country. TGD's dedication to providing top-quality data has been acknowledged by Lancet (Lancet, 2008 Mar 29; 371[9618]:1085-97).

In 2009 TGD has been awarded first prize by the Chamber of Commerce and Industry of Bucharest, and was included in the list of Top 100 best companies.

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Geography

In order to conduct trials that require either large numbers of patients or few patients with rare diseases, it is essential to establish a presence around the world. Towards this TGD is expanding beyond its current locations in Romania, Republic of Moldova and Israel. In Europe we intend to strengthen our position in the Balkan area between 2010 and 2011, with a 2nd wave, planned for 2011-2012, having its target the S.E Asia.

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TGD assets

Our main asset is our network of more than 40 academic sites and investigators, who have already conducted 20-30 trials each. We are familiar with each investigator’s abilities, patients’ population and recruitment rate hence assigning them to studies they can contribute the most to.

Along the way we gain their trust and loyalty. Our study managers and monitors are all trained psychiatrists and psychologists, proficient in all the relevant assessment instruments (PANSS, SANS, ESRS, AIMS, BACS, YMRS, components of MATRICS, and Calgary depression scale, to name only a few). We pride ourselves on being an academically-oriented research organization.

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Goals
Our goal is to provide comprehensive CRO services to small- and medium-size pharmaceutical sponsors.

Our multi-site CRO offers reliability and experience, based on our operations in several countries, at competitive prices.
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TANGENT DATA
115 Popa Nan St.
Bucharest 030581
Romania
ph: +40 21 323 3224
fax: +40 21 320 4432
e-mail: office@tangentdata.com