Regulatory authorities require pharmaceutical, biotech and medical device industries to comply with clinical trial results disclosure and with ethical standard operating procedures to help protect patient’s interests. This is now also transpired into ensuring that companies are committed to publishing the research with ethical practices that meet industry standards, including Good Publication Practice (GPP). Appropriate documentation of publication procedures is imperative in demonstrating your Company’s commitment to ethical publication practices.
Compliance & Monitoring (Clinical Trial Disclosure & Publications)
Publication Database (Knowledgeable with Datavision, PubStrat, PubsHub)
QC & Monitoring
Best Practice Guides & Training
Company’s internal QA check of the publication management database (PMD) revealed that documentation of key author engagement milestones during publication development process was sub-optimal. An improvement in documentation compliance rate was warranted.
In order to ensure long-term sustained improvement, it was critical that publication managers and writers (internal & agency partners) take responsibility and accountability for compliance with documentation. Following steps were undertaken to achieve this:
Adapted PMD to provide consistent documentation of key milestones.
6-month follow-up of internal QA check showed improved compliance rate of >90%.
Metrics help teams & organizations measure success of scientific communication and publication plan objectives, and identify gaps related to data availability and resources. Metrics can vary in their value to different stakeholders, hence the metrics analysis plan will be customized to meet your analysis goals.
Company desired to assess and track the publication group’s productivity and efficiency of publication outputs, and compliance with publication policy. The objectives were to be able to identify process inefficiencies, measure compliance with company policy, help identify potential gaps in resources, etc.
Provided summary report, including recommendations for improvement as needed.
Based on the metrics reports, publication group was able to utilize the data to:
Publication teams could also utilize the data during journal selection discussions with authors (e.g., prior journal acceptance/rejection history).