Catch Errors and Inconsistencies in Your Documents ....Before Management Review and Finalization
We support your teams by performing fast, reliable quality control reviews of all types of regulatory, medical, and scientific documents.
Top 6 Reasons Why QC Reviews Aren't Being Performed
01
Medical Writers Should QC Their Own Documents.
Some companies put the full onus of responsibility for QC reviews on the medical writer responsible for the document. But, we all know, from experience, that you simply won't catch as many errors and inconsistencies when you have written and revised the document countless times.
02
Our Medical Writers Just Review Each Other's Work.
Your medical writers are pressed for time, and, frankly, their time is better used for writing and revising your clinical development program documents.
Most do not have the formal training in document-specific QC review processes, including standardized QC checklists, or the availability to review product or disease state documents across document types to ensure between-document consistency.
03
Our Functional Areas QC Their Own Sections.
Functional areas are typically only focused on those sections for which they are responsible. Subject matter experts are not expected or intended to catch every document quality deficiency.
04
Anyone Can Be a Good QC Reviewer.
Not everyone is good at document QC. Even expert medical writers are often not sufficiently detail oriented and eagle-eyed to spot errors and inconsistencies. Non-native English speakers may not catch grammatical errors.
05
We Don't Have the Time to Review Every Document.
Companies that make document QC review the priority that it should be design a formalized QC review process that includes QC review as an integral step in the clinical development process. As a critical step, QC is included in timelines, and resources are allocated.
With the level of regulatory scrutiny of your clinical development documents and submissions, can you afford not to put your best foot forward?
06
We Don't Have the Budget to Pay for QC Review.
Contracting to professional QC document specialists who are well-trained, highly experienced, and fast will save you time and money compared with the common practice of pulling in internal resources with competing demands on their time or, worse, needing to re-open documents to correct errors or inconsistencies.
"A poor quality document will hinder regulatory review, resulting in unnecessary questions and responses, which, in turn, leads to delay in timeline and waste in resources."
QC specialists are the safety net
that helps to catch errors and inconsistencies in documents and prevent these errors from making their way into other documents used by regulatory agencies, healthcare providers, patients, and the general public.
Nothing Beats a Fresh Set of Eyes: What Makes Our QC Reviewers Great?
- Medical/scientific background
- May be trained as a medical writer but should have no authorship role in documents being reviewed to maintain objectivity and lack of bias.
- Familiarity with and experience in the QC review of all types of regulatory documents
- Regular training on our (and/or your) procedures and standards
- Consistent feedback and audits by our QC Manager foster continual improvement
Document-Specific Quality Control Checklists
Save time by accessing our "done-for-you" document-specific QC review checklists.
On-Demand Online Quality Control Classes
Get your team quickly trained and up-to-speed on how to perform QC reviews on different types of regulatory documents. Learn at your own pace with our on-demand classes.
Customized Quality Control Classes
Let us customize our document-specific QC review classes to fit your internal QC process and style guidelines.