Recent estimates suggest the submission process to regulatory authorities takes from 18 to 30 months. The pharmaceutical industry has invested in process optimization and technology to cut costs and shorten the submission process. Yet, there are still opportunities to unlock additional value in these investments. Paragon works with your clinical operations leadership to improve communications among team members, enhance management oversight and streamline processes to reduce approval time and decrease operational overhead.
eCTD Submissions
Paragon helps life sciences firms implement electronic submissions in electronic Common Technical Document (eCTD) format that conform to FDA and ICH guidelines. Our solution helps streamline the review process and improves the quality and organization of document submissions.
Case Study: eCTD Submissions – Paragon replaced a manual, paper-based system with global eCTD Submission software to enable the client to process submissions to health authorities electronically.
Aggregate Spend
Life Sciences firms are under ever-increasing pressure to adhere to regulatory and industry guidelines. Recent mandates require that pharmaceutical and medical device manufacturers evaluate the social and financial cost of current Healthcare Provider (HCP) acquisition strategies to avoid the appearance of impropriety. Paragon understands the application infrastructure and data issues associated with aggregate spend, as well as the potential for using the advantages of “situational awareness” to analyze and forecast the benefits of different sales and marketing models.
Case Study: Aggregate Spend - This pharmaceutical client was using ad hoc processes, Excel spreadsheets and desktop databases to gather and report Health Care Provider (HCP) Aggregate Spend for Vermont, Michigan and California regulators. Paragon to supported the client's compliance steering committee with regulatory response recommendations, a comprehensive roadmap of ‘To Be’ business processes, and the supporting data management and reporting strategy.
Standard Operating Procedures (SOP) and Critical Document Management
SOP documents are involved in a number of regulatory processes and Paragon’s experience with business process management and enterprise content management delivers an integrated approach to efficient workflow and access to SOPs.
Quickview for DocumentumTM
Paragon has developed its own solution which publishes secured content such as SOPs, to a local site or portal for view by consumers. The solution allows for the publishing of not only the documents, but also the watermark and e-signatures. The user can easily search for the document in a variety of ways including document taxonomy and key words. Additionally, the solution enables the user to print the document to a local or network printer and have a time and date stamp associated with the print.
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