Clinstat Inc.
Kingston, ON
Company Overview
Clinstat Inc. consists of a team of research scientists (clinical and engineering) with regulatory experience.
Our focus is to provide support services to small and mid size companies (pharmaceutical, nutraceutical, natural health product (NHP) and medical device industries).
This includes: scientific literature searches and reviews, regulatory submissions, product license applications, web-based data management solutions for clinical trials, and other CRO related activities (e. g. study monitoring, data analysis).
Company Information
Physical Address
205-920 Princess St
Kingston, ON K7L 1H1
CA
Mailing Address
205-920 Princess St
Kingston, ON K7L 1H1
CA
Additional Details
Legal Name: Clinstat Inc.
Number of Employees: 3
CA
1: Our directive is to assist small to mid size companies with our regulatory experience with Health Canada.
2: We provide web-based data management solutions for clinical trials which meet regulatory requirements, including those of Health Canada and the US Federal Regulations (FDA, 21 CFR Part 11 - Electronic Records; Electronic Signatures).
While the list of our customers has to remain confident, for a description of past-projects, please consult our web-page:
http: //www. clinstat. ca/past, projects. htm
Office Size: 1100 sg ft
Clinstat Inc. has presently 3 full-time staff members; two of which have a Ph. D. in the health field, and one an M. Sc. in the computing and networking field. Each of these staff members have more than 15 years of work experiences.
In addition, we hire part-time members on an as-needed basis, or other specialists, from the local, university based, community (Queen's University, Kingston).
Contacts
Heinz-j. Biedermann
Title: President
Area of Responsibility: Management Executive
Phone: Show phone
Fax: Show fax
Email: Show email
Marleyne Mauri
Title: Director
Area of Responsibility: Management Executive
Phone: Show phone
Fax: Show fax
Email: Show email
Services
- 1: Natural Health Product (nhp) Consultant - Canada
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2: Herbal Consultant - Canada
Please see 'Natural Health Product (NHP) Consultant'
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3: Nutraceutical Regulatory Consultant - Canada
Please see 'Natural Health Product (NHP) Consultant.
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4: Nutritional Supplement Consultant - Canada
Please see 'Natural Health Product (NHP) Consultant'
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5: Product Research & Literature Research
Background research on specific products (e. g. one to be imported, bought or to be marketed by a company in Canada.
Exhaustive reviews and reports which document and summarize the evidence found. Where applicable, this may include use of clinical data provided in publications, conference proceedings and the like, with a view towards regulatory standards.
In depth scientific literature searches (pharmaceutics, natural health products) in support of a product's claim (effiacy, safety, toxicity, contra-indications, warnings and cautions).
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6: Data Management - Clinical
Remote and Secure Web Based Data Entry:
Our ClinStatRemote high performance data management system is a flexible and fully scalable web application for the collection of clinical data (eCRF) and the full management of a clinical trial. It makes use of the latest rapid application development tools and retains all data in high performance relational databases. Given its power, its performance will be the same whether there are 3 or 300 sites connected to this application.
ClinStatRemote is an excellent replacement for more traditional methods of data submission (e. g. paper and faxed CRFs), and its functionality has been specifically developed to include technical features required by US Federal Regulations, 21 CFR Part 11 - Electronic Records; Electronic Signatures.
ClinStatRemote is product specific, making use of our pre-existing programming libraries; our staff requires only a short lead time to have it ready for your particular use.
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7: Clinical Trial Consultant
Development, coordination, monitoring, data management (including web-based solutions) of clinical trials for pharmaceuticals, medical devices and natural health products.
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8: Medical Device Consultant - Canada
please see 'Clinical Trial Consultant'
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9: Regulatory Affairs Consultant - Canada
We assist you with the completion of regulatory applications required by Health Canada concerning the testing and licensing of natural health (NHPs) and pharmaceutical products. If required, we represent your company at regulatory meetings (third party authorization), or partake in meetings between your company and Health Canada.
Additional Information
541690, 541990
R019-Other Professional Services
Belgium, Cuba, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom, United States, Venezuela