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Registration is now open for the 2nd EMWA/ICR joint symposium in London on 24th February 2008. Places limited so don’t delay.
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 Top Quality Documents Ltd |
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Top Quality Documents Ltd
69 Tupwood Lane
Caterham Surrey
UK
CR3 6DD
Email: info@topqualitydocuments.co.uk
Web: www.topqualitydocuments.co.uk
First Name: Beth
Last Name: Neill
Phone: +44 (0) 1494 870 037
Mobile:
Skills And Services Offered:
Quality Review is the core service provided by Top Quality Documents (TQD). Professional quality experts provide an independent extensive review of your clinical and regulatory documents, complementing those of your statistical, clinical and regulatory teams and ensuring your documents meet the highest quality standards.
We review clinical study reports, protocols, investigator brochures, safety updates and regulatory summaries covering;
- Compliance: with your internal guidelines/templates/style guides and external regulatory guidelines
- Consistency: of information within a document/across a series of documents, including verification of 100% in-text numerical data against sources, spot checks on derived data and that interpretive findings are consistent with data
- Clarity: of language, data presentation and supportable concise arguments
- Completeness: of cross referencing
- Correctness: of grammar, spelling and punctuation.
A comprehensive report is provided identifying individual findings.
TQD also offers a writing service for early phase clinical documentation, patient narratives and Clinical Trial Register Summaries.
Expertise:
TQD is a specialised pharmaceutical consultancy, based near London, which provides a quality review service to pharmaceutical and healthcare organisations, to help you deliver high quality documentation. Our professional approach ensures that your documents are of a consistently high standard and meet international regulatory requirements.
Each TQD associate has a degree in a biological science, has a keen eye for detail honed by years of experience in reviewing regulatory documentation and a good knowledge of drug development and submission processes gained in the pharmaceutical industry across a wide range of therapeutic areas. We work closely with your project teams and understand the need to meet the timelines dictated by regulatory deadlines. We maintain knowledge of current guidelines and regulations for industry-specific documents including ICH guidance, Code of Federal Regulations and other regulatory requirements.
Other Information:
Your documentation represents the culmination of years of expensive research and development. It pays to continue to invest in ensuring your documents are of the highest standard and quality; the final output will influence the success of your project.
Benefits of our review:
- Provides an objective review; writers are often too close to their own documents and involved in the creative aspect to see errors
- Frees up specialists to focus on their areas of expertise and increases efficiency
- Provides early identification of critical issues
- Decreases the chance of regulatory agencies delaying approval due to the quality of the documents submitted
- Ensures a consistent standard is established across a series of documents to allow a faster review
- Minimises irritating minor anomalies, so everyone is given greater confidence in the quality of the document.
Please contact TQD to discuss your individual needs.
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