FAQ
What is a CRO?
A CRO is an independent organization that provides defined research services to pharmaceutical, biotechnology, and medical device industries to help answer their specific health or scientific questions. A CRO is fully focused on the clinical trials process, usually entering the development process once a client has identified a promising new molecule or prototype. The CRO will then activate their extensive expertise and professional network in this field to organize, conduct and evaluate clinical trials and provide an objective assessment in a clinical setting.
What is a CRO?
What are the benefits of working with a CRO, like TCA?
How can TCA help manage risk?
What are the benefits of conducting a clinical trial in Israel?
What therapeutic areas of expertise does TCA offer?
What range of services does TCA offer?
What regulatory and ethical principles govern your TCA clinical trials?
Do you cover all four phases of the clinical trial process?
How are you able to expedite the process?
TCA Clinical Research Limited delivers an entire team of proven professionals with specialist research capabilities. Making use of the wide range of TCA services involves much less risk, cost and time-to-completion than applying the client’s own internal resources and staff. What’s more, many research projects may demand particular areas of experience, skills and access to resources that are either scarce or absent in the client’s organization or region. TCA saves clients significant resources when analyzing regional and even site-specific trial feasibility, as well as contributing a deep insight into local site, investigator, patient recruitment and regulatory practices.
Our extensive network, experience and training covering a vast range of therapeutic areas provides specialist knowledge that ensures your project’s outcome is successful. Added to this we assess every project for early identification and resolution of any elements or procedures that could delay or hinder the trials’ implementation and smooth operation.
Israel is a respected player on the technology, healthcare and medical development global stage, home to many leading medical experts and claiming the highest number of scientists and doctors per capita in the world. In addition to this, Israel has proved very accommodating for clinical trials thanks to a number of reasons:
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Easy investigator and patient recruitment in most therapeutic areas
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Professional medical centers that meet the highest standards and regulatory criteria
A majority of multilingual GCP trained investigators, study staff and clinical site personnel -
Support for Electronic Data Capturing (EDC) and other advanced technological tools
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Short approval process cycles
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Reduced study costs as compared with Europe and North America
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Full patient coverage by the national social security system and affordable public health insurance providers who also operate some of the country's most prestigious medical centers
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An extensive and impressive network of medical schools, medical centers and primary care units, retaining tens of thousands of physicians who are highly involved in research and clinical trial programs.
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Israel is populated by a variety of ethnic groups, allowing a broad population diversity to be incorporated into clinical trials. This is crucial when considering the different effects a medical product can have on various patient populations.
TCA Clinical Research Ltd. is ideally positioned, with long-standing investigator relationships throughout the country and deep familiarity with regional medical centers, procedures and language. Our excellent local reputation ensures faster and cost-effective results.
TCA Clinical Research Limited has accumulated more than 20 years experience, today reflecting the following therapeutic areas – Oncology, Gastroenterology, Respiratory, Nephrology, Gene Therapy, Cardiovascular, Ophthalmology, Metabolic Disorders, Hematology, Hepathology, Pulmonary, Rheumatology, CNS and Neurology.
TCA Clinical Research Limited full range of services includes:
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Project management
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Clinical monitoring and site management
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EC and CA regulatory affairs
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Feasibility and site selection
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Informed consent development
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CRF design
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Study file setup
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Site contract and budget negotiation
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Investigator meetings organization
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Translation and validation of study documents
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Medical writing and documents development consultancy
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Site study coordination
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Quality management
We follow a very clear protocol - a defined set of directions set out by our client. This not only determines how long the study will last, but what will be the structure of the trial, what type of population is eligible to participate, as well as the testing schedule, types of medications, dosages and other resources to be used. We also adhere to strict international standards that regulate the conduction of clinical trials: ICH-GCP guidelines, sponsor’s SOPs (and/or our own SOPs), FDA regulations and Israeli Health Authorities' regulatory procedures.
We follow three key ethical principles when conducting trials: Firstly that based on the Hippocratic Oath of no harm to those involved or affected by the trial, secondly respect for the participants’ right to confidentiality and thirdly an ongoing risk/benefit assessment – there must always be a sufficient body of scientific and medical evidence to justify the trial.
We conduct all four phases of the clinical trial life-cycle. In Phase 1 clinical trials we test the drug or treatment with a healthy group to ensure safety, establish dosage range and discover any possible side effects. Phase II clinical trials give the same drug or treatment to a wider group, including those patients with the disease in question. This also tests the level of safety and effectiveness of the drug. Phase III clinical trials see a much larger population exposed to the drug or treatment including patients suffering from the disease in question, allowing comparison with existing treatments and collating a wealth of data that can contribute to safe future use. Finally Phase IV clinical trials are performed post FDA approval and public marketing of the drug or treatment. This stage continues to build data on the safe use of the drug and the more long-term side effects.
Our local expertise streamline the administrative and bureaucratic elements of the process, and also our long-term and established network across multiple local sites. Being located so close to leading medical centers, hospitals and out-patient clinics also ensures significant time and cost savings. Our familiarity with the procedural requirements per local site accelerates site contract negations and agreements, along with ethical and regulatory approvals.
5 Florentine St., POB 504, Tzur Moshe, 4281000 Israel