Knowledge Center

Challenge: An international clinical trial company developing a custom Clinical Trial Management System (CTMS) required a software design that significantly reduced the cost of deploying CTMS for each new trial.

Solution
Designed and developed a sophisticated randomization scheme generator which once validated created new protocols that were validated at the time of creation while simultaneously complying with GxPs and 21 CRF Part 11.

Return
Significantly reduced overhead costs and increased customer satisfaction with each new trial because new trial protocols did not require validation.

An early stage medical device company intended to enter the Australian Market in one year’s time and needed a strategic compliance roadmap to meet the requirements of FDA 510K clearance, CE marking, UL marking, Canadian CMDCAS requirements, and the Australian AS/NZS 3200 Suite of Standards for Medical devices

Solution
Designed and developed a sophisticated randomization scheme generator which once validated created new protocols that were validated at the time of creation while simultaneously complying with GxPs and 21 CRF Part 11.

Return
Significantly reduced overhead costs and increased customer satisfaction with each new trial because new trial protocols did not require validation.

A global research organization found their projects jeopardized because the research staff consistently avoided project validation requirements due to their misunderstanding of their importance for their business, operational and scientific needs.

Solution
Customized validation training program that demonstrated the value of the organization’s SOPs by applying them to commonly used objects in a way that produced immediate appreciation of their benefit.

Return
Willing compliance with internal standards, improved quality and increased client satisfaction.

FDA found web-based software tracking cGMP applications at a large pharmaceutical company out of compliance.

Solution
Redesigned web based inventory application and implemented new design to meet 21 CFR Part 11 requirements.

Return
Company successfully demonstrated regulatory compliance which ensured continuity of manufacturing operations.

Large biotherapeutics company in reorganization sought out-sourced hosting company for over 100 critical business systems with the need that the new vendor could from day one successfully withstand a FDA inspection.

Solution
Quality Management System and compliance audit of several third party specialized IT services providers vertically focused on Pharmaceutical, Healthcare and Financial Services companies. The audit focused on compliance, detected risks and risk remediation recommendations.

Return
The biotherapeutics company confidently chose a new IT vendor and successfully migrated business solutions to a cost saving environment.

An emerging software company developing a life science application had little experience with FDA regulations, which caused significant delays in their commercialization strategies.

Solution
Developed for the company a framework that included intensive regulatory training, the backbone of a Quality Management System and a software validation strategy.

Return
A successful and more cost effective commercialization effort that delivered to the market an FDA compliant system.

A medium sized pharmaceutical company recognized the economic value of adopting Software-as-a-Service (SaaS) solutions for managing critical data but did not have in place the SOPs and validation processes appropriate for SaaS solutions.

Solution
Evaluated the completeness and accuracy of SOPs in describing validation process steps required by industry standards,
created a gap analysis of process steps required to ensure compliance and filled gaps by authoring SOPs.

Return
Regulatory compliance for managing critical data in preparation of an electronic submission to the FDA.