Simplify, Streamline, and Speed-Up Your Clinical Trial
Project Management Services
We support you in all aspects of project management, right from early phase to late phase Clinical Trials. Our solutions are guided by well-defined standard operating procedures that comply with all applicable industry regulations and guidelines. With us, you can manage your Clinical Trials effectively — from consulting and scoping to monitoring and reporting.
Project Management Plan
Our team of Project Experts help you devise structured project plans for decisive communication, project governance, risk assessment, and risk treatment. Our service enables a detailed breakdown of work that factors in risk mitigation, thereby helping you overcome project setbacks and ensuring on-time delivery without budget overruns.
Setup Validation
We deploy precise qualification procedures to validate the Study Database. Internally, we put the database through rigorous testing before it is released for User Acceptance Testing (UAT). Our Stringent Quality Control practices focuses on maintaining validation checklists and documenting approvals, ensuring regulatory compliance.
User Acceptance Testing
We ensure that the database is configured to your requirements by devising a detailed test validation plan and test scripts as part of our validation procedures. Also, standard documentation for user acceptance testing (UAT) validation sign-off and traceability matrix is maintained for all testing.
Study Database Setup and Configuration
Our team of designers develop and configure study databases following thorough protocol interpretation and database arrangement based on an elaborate mechanism. Also, the Clinical Database is configurable and flexible to incorporate mid-study changes without disrupting the trial in progress.
Study-Specific
Training
Our elaborate Training Modules include interactive instructor-led training, self-learning videos, learning exercises, and on-premise training. This helps your workforce use our solutions efficiently for both general and study-specific transactions.
Project Support
Consistent reviews, along with our advanced discrepancy manager module, help you identify data issues and ensure a clean and complete database for the final analysis with data exports in .csv and .xls formats post database lock.
Support Center
We deploy a dedicated and highly accessible Support Team to each project for guiding, supporting, and empowering our customers. Our solutions enable effective planning, streamlining, monitoring, and reporting to deliver strong Study outcomes on time and well within your budget.
Project Closure
We follow well-defined procedures for maintaining and archiving Study documentation, verifying the completion of all Study processes, closed sites, and system decommissioning. Also, we generate and analyze Study Reports to provide insights on overall strengths and weaknesses.