Top Quality Documents

Solutions for Quality Documentation

 

 
 

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.

Quality Review

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 data review and validation service for ongoing clinical trials and a writing service for subject narratives and Clinical Trial Register Summaries.

Testimonials

"Thanks for the quick turnaround! All comments are clear as usual. Always appreciate your viewpoint since we get lost in the details and timelines when writing , and need someone to review the whole document" Senior Medical Writer, Stiefel