Full-cycle IT Project Implementations
Bringing to bear our network of skilled and experienced resources we are equipped to provide full-cycle IT project implementations for our clients.
Building on the specific consulting services we are known and respected for we can bring in the additional team members necessary to drive IT projects through the full System Development Life Cycle.
Specialized Pharma System Implementations
Strategy for Regulatory Information Management Systems.
Gap analysis and Implementation strategy for R&D Applications.
Data Migration for Drug Safety & Regulatory Data.
High Level Requirements
Request for Proposal (RFP)
Vendor Analysis & System Selection
Setup Project Steering Committee
Project Charter & Project Plan
High Level Architecture
Regular Status Reporting to Stakeholders & User Group Meetings
Technical Implementation in Development & Validation
System Requirements, Configurations, & Design
Formal Validation including GxP protocols
User Training & SOP Development
Post Implementation Support
Project Documentation Archive
Survey – Lessons Learned
GAMP 5 Validation Methodology
We support all facets of the risk-based GAMP 5 validation standard for compliant GxP computerized systems.
We help our clients to effectively & efficiently manage & perform Computer System Validation projects to industry best practices and FDA requirements.
Validation Planning, User Requirements, and Design Specifications
Installation, Operational, and Performance Qualification
IT-R&D Application Support
We offer excellent cost effective application support & maintenance services. Our dedicated team of IT professionals provide remote support and maintenance for your applications.
We focus on comprehensive application management to improve end user experience.
We have the knowledge base to support Regulatory, Quality, Adverse Event & Dictionary Management, and Clinical & Bio Statistics.
Application Support & Maintenance Services
We line up with customer support and administration procedures.
We focus on overall system health, we believe that only a well-maintained system can improve user experience.
We work with both on call (retainer based) and dedicated support models.
Our comprehensive application management covers ramp up, system administration, regular maintenance, break-fix, and periodic service reviews.