G7 Synergon’s Clinical Operations team conducts Phases II-IV clinical trials by maintaining the highest standards of ethics, quality and confidentiality. We promote a team approach with emphasis on

management, support, recognition, training, accountability and personal development. To ensure our clients receive quality monitoring services in compliance with the applicable regulatory guidelines, we provide comprehensive training and development programs to our Clinical Research Associates (CRAs).

Feasibility And Planning – Key To A Successful Completion Of The Study

Feasibility looks into the disease prevalence, incidence rates and current pattern of enrollment in similar trials or therapeutic areas. Besides considering medical, statistical, ethical and regulatory requirements, comprehensive feasibility report, helps to make critical decisions of the planned study. Trial specific risk assessment and quality planning are an integral part of our trial preparation procedures.

Project Management

Team Approach – We Streamline Our Team According To The Clients Needs

G7 Synergon understands that project management is integral part toward the success of a clinical trial. The project Management team is responsible for ensuring that studies are kept on track as per the regulatory norms. Outsourcing your project management needs to G7 Synergon simply means, your project would be managed by a highly dedicated interdisciplinary team, steered by a project expert, who is the key point of contact with the client, for any issues throughout the project. We have an outstanding track record of continuity in our project management teams, which in turn significantly facilitates communication with the clients study team. Project teams are trained in advance for each study with regard to the study's medical background, study goals and study plan.

Our Project Management services include:

•  Project Management Planning
•  • Feasibility and Patient access Planning
•  Subject Recruitment & Retention Strategies
•  Collecting and Reviewing initial Essential Documents
•  Ethics committee Submission /Approvals
•  Therapeutic and project specific training
•  Clinical Trial Agreement preparation
•  Detailed risk assessment including risk management plans
•  Project budget controlling

Monitoring

All trials are monitored in accordance with G7 Synergon’s Standard Operating Procedures (SOPs) developed to meet Good Clinical Practice (GCP) standards. Our CRAs have considerable clinical research expertise and broad therapeutic experience on an Electronic Data Capture (EDC) platform. We have co-monitoring and training programs to ensure ongoing quality, consistency and up-to-date knowledge in our monitoring.

At G7 Synergon, we believe that monitoring is not only about making sure that the project runs smoothly with minimum protocol violations and low query rates but also about delivering personalized service. By having empathy for people, our CRAs produce a dynamic, rewarding and mutually beneficial site and client relationship.

Monitoring services include:

• Assessing sites for feasibility to conduct study
• Investigator site selection and Set Up
• Pre-study Qualification visits
• Conducting Investigator Meetings
• Initiation of the sites on completion of startup activities
• Periodic Monitoring visits
• Study Close Out Visit
• Source Data Verification
• Adverse Event management
• Submitting close out reports to Ethics committee
• Query Resolutions