Clinical Trial Audit and Monitoring Services

Clinical Trial Audit & Site Monitoring Services

Clinical Trial Audit & Site Monitoring Services

Our highly trained clinical research associates (CRAs) ensure integrity of study and commitment to excellence—on par with the study protocols, clinical monitoring plan, standard operating procedures, and ICH-GCP standards.

Efficient monitoring of clinical sites from site qualification to report generation with a high level of transparency – Site, Patient & Study

Clinical monitoring is a critical and expensive, aspect of your trial. Pepgra offers risk-based high-quality services in clinical trial monitoring to ensure scientific excellence and data integrity across operational centres and regional hubs. Our in-house project management and operations team travel across the globe to support project teams through our local knowledge of the regulatory environment (ICH-GCP) and current industry best practices. We will stand shoulder to shoulder with you on-site—with commitment, passion and motivation to maximize the potential of everyone.

Our experts ensure perfect coordination among clinical research associates, project managers, sponsors, and other clinical trial site members.

Our trained staff has therapeutic experience in

  • Oncology
  • Gastrointestinal Disease
  • Respiratory Disease
  • Cardiovascular Disease
  • CNS Disease & Pain
  • Diabetes
  • Infectious Disease

Pepgra’ s Comprehensive Clinical Trial On-site Monitoring Solutions

  • Site selection and feasibility
  • Site initiation visits
  • Site interim monitoring, and study closure visits
  • Source document review and case report forms
  • Report generation [facts, deviations, deficiencies, conclusion)
  • Quality assurance mechanisms
  • GCP—including training and motivational visits
  • Communication with sites
  • Customizable training based on the requirements
  • Managing of local ethics review process
  • Study-specific training to site personnel
  • Development of Tracking system – customized source data verification checklists and subject status tracking system.
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Pepgra has done plethora of work in the area of clinical trial audits and monitoring for top pharmaceutical companies. Our CRAs will ensure a thorough review of data, frequent the sites, and perform interim analysis. All tasks in compliance to ethics committee and regulatory standards such as Schedule Y, study protocol, ICH GCP and the other regulations.

 
 

We deliver study designs balanced to meet your business needs and expectations with the current scientific understanding and all regulatory requirements considered.

Allow us to help propel your product forward.

 
Pepgra CRAs did a fabulous job of frequenting the clinical trial sites at different times during the course of study. Apart from their technical know-how, they also had a great affinity with our site team members and finally documented pivotal research findings in the monitoring report which was an eye-opener for us. I would strongly recommend Pepgra as the CRO of choice.

— Barry Stein, VP of a leading medical device manufacturer.

We’ll scale

up as your needs grow.

No compromising on integrity and quality. Our processes are well defined and flexible to ramp up as per your requirements.

 
 

Have a business query? Let’s talk.

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