Cost Saving CTMS Design for Pharmaceutical Company

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.

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

Accelerated Commercialization for Medical Device Company

Challenge:  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:  A strategic roadmap structuring a compliance path that built a quality system enabling the company to first meet FDA, then European and Canadian, and finally the Australian requirements. 

Value Creation:  The strategic roadmap unexpectedly created a preemptive opportunity to enter the more lucrative US market first and 6 months ahead of schedule.

Compliance Through Customized Training 

Challenge:  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.

Value Creation:  Willing compliance with internal standards, improved quality and increased client satisfaction.

483 Warning Letter Remediation

Challenge: 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.

Value Creation:  Company successfully demonstrated regulatory compliance which ensured continuity of manufacturing operations.

Vendor Audit for Out-Sourced Hosting Solution

Challenge:  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.

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

Quality Framework and Validation Strategy for Life Science Software

Challenge:  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.

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

SaaS Solution Validation and Compliance Effort

Challenge: 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. 

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