Clinical Trial Audit & Site Monitoring Services
Services
- Clinical Trial Audit & Monitoring
- Clinical Study Design
- Global Regulatory & Clinical Writing
- Clinical Biostatistics
- Clinical Trial Patient Recruitment
- Regulatory Affairs
- Clinical Data Management
- Post-Market Surveillance
- Clinical Technology & Process
- Healthcare Analytics
- Global and Local Literature Search Screening
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
Pepgra’ s Comprehensive Clinical Trial On-site Monitoring Solutions
Brochure
Biostatistical capabilities
Changing global regulatory system, globalization of clinical trials, increased consumer expectations, infrastructural and culture issues, and various diagnostic requirements should never hamper your research and development programs. With our support…. Read More
White Paper
Clinical evaluations
Clinical Evaluation Report (CER) in a more Stringent Regulatory Environment- Now, subject to more intense scrutiny by Noti¬fied Bodies…Big Data in IoT for Healthcare Read More
Blog
Medical writing
The requirements for medical writing are witnessing continuous growth influenced in good portion by the mounting government scrutiny and… Read MorePepgra 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.
Partnering with
you till the project end.
We come with you all the way. From design to market support
Pepgra CRO Offerings
"Changing global regulatory system, globalization of clinical trials, increased consumer expectations, infrastructural and culture issues, and various diagnostic requirements should never hamper your research and development programs. With our support..."
Download brochure on our CRO offerings (PDF).
