Clinstat Inc.
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 Details
Year Established:
1989
Number of Employees:
3
Company Information
Heinz-j. Biedermann
Title:
President
Area of Responsibility:
Management Executive
Telephone:
(613) 546-4130
Fax:
(613) 549-8012
Email:
Click Here
Marleyne Mauri
Title:
Director
Area of Responsibility:
Management Executive
Telephone:
(613) 546-4130
Fax:
(613) 546-4130
Email:
Click Here
Services
1: Natural Health Product (nhp) Consultant - Canada
7: Clinical Trial Consultant
Development, coordination, monitoring, data management (including web-based solutions) of clinical trials for pharmaceuticals, medical devices and natural health products.
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.
8: Medical Device Consultant - Canada
please see 'Clinical Trial Consultant'
3: Nutraceutical Regulatory Consultant - Canada
Please see 'Natural Health Product (NHP) Consultant.
4: Nutritional Supplement Consultant - Canada
Please see 'Natural Health Product (NHP) Consultant'
2: Herbal Consultant - Canada
Please see 'Natural Health Product (NHP) Consultant'
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).
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.