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4174 Dundas Street West Suite 300
Toronto Ontario Canada M8X 1X3
Canada
Toll free: 1-800-915-9315
Phone: 416-231-8008
Fax: 416-231-1422
E-Mail:
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Please notice: This entry hasn't been updated by the submitting company for more than 2 years. It could be possible that this company doesn't longer exists.
Description:
Established in 1986 SciAn Services is a Contract Research Organization (CRO) servicing drug development programs for multinational pharmaceutical, biotechnology and medical device companies participating in clinical drug development programs in all 4 phases of clinical trials. SciAn has offices in Pennsylvania, California and Toronto, Canada. We specialize in:
1. Study design and protocol development;
2. Data management (Paper, Fax or EDC- compliant with FDA 21 CFR Part 11);
3. Biostatistics;
4. Clinical research report writing, medical and manuscript writing;
5. Trial/site/project management; and
6. Regulatory support. We have completed 605 studies in most therapeutic areas in all 4 phases of clinical trials. We have designed, managed and analysed clinical studies ranging from small complex Phase II Cancer studies and large multinational registration trials (exceeding 5 years in duration with more than 2,000 subjects) to phase IIIb, phase IV post-marketing studies and phase I Pharmacokinetic -and dynamic evaluations. SciAn Services has the experience and knowledge to cost-effectively collaborate with drug companies to develop drugs from the pre-clinical stage to phase III pivotal trials for submission to FDA, TPD and EMEA and phase IV post marketing studies; or any clinical phase therein. SciAn Services will provide the experience, competencies and regulatory standards of a large CRO with the flexibility, efficiencies, open communication, and cost-effectiveness of a smaller CRO. As such, SciAn meets the healthcare industry's demands for flexible, cost effective and leading edge clinical research support through its ability in delivering data management, analysis and project management services that benefit its clients through increased speed to market, client control over data and successful regulatory submission compliance. The following is a summary of our key services: Clinical Data Management
· Data entry from CRFs
· Electrinic data capture (EDC) compliant with FDA 21 CFR Part 11
· Data entry - fax-based systems
· Fast, accurate & cost-effective data management solutions
· Detailed SOPs to ensure the accuracy and integrity of information Bio-statistics
· Statistical data monitoring & central randomization
· Statistical analysis
· Statistical, integrated reports & manuscripts
· Study design, protocol & clinical program development
· Statistical support for regulatory submissions Clinical Trial Management
· North american trials/investigational sites
· Study initiation & training
· Site monitoring
· Project management
· Regulatory document support
· Integrated trial & data management Clinical Research Information Systems
· Serious adverse event tracking and reporting system
· Integrated summary of safety and efficacy databases
· In-house information/project management systems
· Integrated trial & data management system
· Reliable, secure & cost-effective solutions
· Secure systems accessible over the Internet or dedicated connections
· Systems housed at client and/or at SciAn Therapeutic Area of Experience: · Arthritis;
· Central nervous system
· Cardiovascular system
· Contraceptives
· Dermatology
· Devices
· Endocrinology
· Gastroenterology
· Immunology
· Infectious diseases
· Men's Health
· Obstetrics
· Oncology
· Ophthalmics
· Organ transplantation
· Respiratory
· Vaccines
SciAn Services is compliant with all regualtory requirements. Our systems and SOPs have been audited by an American independent 3rd party to ensure compliance with all applicalbe ICH standards (E3, GCP, E8, and E9), FDA Guidance for Industry: Computerized Systems Used in Clinical Trials, and FDA 21 CFR Part 11.
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Last update of this entry: August 25, 2010
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