Over the past 20 years, Prelude has been able to provide tangible results to our business partners. We have a solid reference base of small businesses to Fortune 500 companies where we have deployed highly successful solutions. Here is a sample of the benefits our partners have realized.

Getting Product to Market Faster

Automated the New Drug Application process, reducing time spent preparing documents and getting product to market shelves months faster. Installed, trained, and validated Document Management and Publishing systems for Electronic Submissions. Required compliance with FDA regulations such as 21 CFR Part 11, Guidance for Industry Documents, and validation.

Better Trend Analysis

Simplified the Adverse Event reporting system for the Director of Medical Affairs to make it easier for staff to produce reports and look for trends and patterns in adverse events. This system was implemented in accordance with Part 11 and FDA regulation.

Expanding Business Intelligence

Provided the Vice Presidents and Directors of Scientific Affairs with tools that enabled them to track expenditures and labor on all Scientific Affairs projects. These new tools gave management a better means to anticipate project requirements, deploy resources, and track results. Examples include: labor tracking, budget vs. expenditure tracking, submission planning, clinical supplies management, and internal audit tracking.

Business Process Improvement

Created the business case for automating the New Drug Application process uncovering immediate improvements that were made to business process. Created a project plan and budget for the implementation of an Electronic Drug Submission system.

Spearheaded a team comprised of the entire documentation department that examined all day-today work processes.  We removed inefficiencies and streamlined the process for receiving and tracking documents across four physical sites and freed up two staff members.

Worked with management to develop an overall Document Management Strategy and life cycle management.  Strategy included the paper records life cycle management and tracking as well as the implementation of a new Documentum document management system.

Improved Service Delivery

Improved productivity by moving paper and Word based request forms to self service SharePoint web forms based solutions. Reduced turnaround time, captured response and volume metrics for continual improvement, improved user experience.

Introduced a novel way of staffing the help desk that reduced turnover by 80% and that more than doubled employee satisfaction with the help desk response.

Faster Turn Around

Reduced turn around for responding to FDA inquires from days to minutes by organizing and indexing documents that were used as the basis for submissions. During one FDA audit the regulatory staff was able to respond to all inquires while the FDA was on-site. This vast improvement resulted in satisfactory response from FDA.

Enhanced Compliance

Project management for SOP Integration and Harmonization team consolidating GxP SOPs resulting from company merger. Reduced the total number of documents by 50% and number of SOPs by over 95% implementing hierarchical system. 

Automated SOP creation to improve customer compliance with FDA Part 11 and speed the process of review and approval via electronic routing. 

Project Management for Pharmaceutical Science Documentation Compliance Project.  Consolidated retention schedules and physical documents reducing compliance risks.

Developed and implemented a central tracking system to centralize management and storage of GxP documents and records. Moved all GxP documents from individual departments to central storage, cataloguing, and changing the appropriate SOPs within an 18 month timeframe.

Electronic Record and Signature Compliance

Automated SOP creation to improve customer compliance with FDA Part 11 and speed the process of review and approval via electronic routing.

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