|
 |
The Quality Review
The Quality Review is the core service provided by Top Quality Documents. Its focus is to provide a thorough and extensive review
of your regulatory and other documents.
 |
|
The review can be conducted in advance of or in parallel with your internal peer review. It is an independent
review by professional quality experts, complementary to those of your statistical, clinical and regulatory teams and is dedicated to
ensuring your documents meet the highest quality standards.
|
All aspects of a document are reviewed, including:
|
Compliance
|
with clients’ internal guidelines and external regulatory guidelines in terms of required content and format
|
|
Consistency
|
100% of in-text numerical data verified against sources provided, spot checks on derived data, interpretation
of findings consistent with data provided, consistency of information both within a document and across a series of documents
|
|
Clarity
|
preventing ambiguity, checking for concise data presentation including appropriate use of tables or figures,
supportable concise arguments, continuity of style both within a document and across a series of documents
|
|
Completeness
|
all sections and appendices identified and provided as required, accurate cross referencing to source data and/or
publications
|
|
Correctness
|
grammar, typographical errors, punctuation
|
The Quality Review is conducted according to standard processes and this can be tailored to your exact requirements. A comprehensive report is provided to the client in an agreed format, identifying individual findings for each document.
For a list of documents which we typically review click here
Top Quality Documents also offers a writing service for early phase clinical documentation, subject narratives and Clinical Trial Register Summaries.
|
|