Your trusted clinical research partner, every step of the way

Deep and broad expertise in planning therapeutic development pipelines and operationalising protocols. Our consulting services start the very first day you engage us on a potential project. We are able to provide the relevant input, in-country knowledge, and expertise to enable our customers to execute the right protocol strategy for their projects.

We provide start-to-finish project management services for clinical studies to drive operational efficiencies and maintain patient safety and data integrity. Our dedicated team of project managers will become your key contact throughout all stages of the project and will be deeply embedded in your team. We provide a complete 360 project management solution, including all aspects of status reporting, budget, third-party vendors and milestone management.

Accurate and reliable clinical data allows us to assess whether a study’s primary and secondary endpoints have been achieved and is also the key component of any application for regulatory approval.  We look to take data management off the critical path with an innovative and agile approach to cater to different protocol complexities. We work with industry standard electronic data capture (EDC) platforms, including Veeva EDC and Viedoc EDC.

Our flexible clinical data management solution includes:

• Database design and development
• Provision of CDISC/SDTM compliant datasets
• Medical coding
• Data transfer and API integrations
• Query design and validations
• Preferred EDC platforms
• Data reconciliation (including SAE reconciliation)
• De-identification of data
• Study status Reporting

Our philosophy and approach to clinical trial site management and engagement isn’t like your typical CRO. Our integrated site research network, spanning more than 350 centres across the globe, gives us a unique, fresh perspective on site management. We understand the very real, practical challenges faced by trial sites and on-the-ground teams, and anticipate and resolve potential roadblocks before they arise.

Our services include:

• Investigator recruitment and ongoing engagement
• Site identification and feasibility studies, site selection and qualification
• Site Initiation
• Site personnel training and education 
• Management of patient recruitment
• Therapeutic supply logistics
• Monitoring of clinical trial data
• Direct-to-site communication

GenesisCare’s highly experienced global Quality Assurance team has deep and broad experience in all areas of quality assurance and knowledge of GCP guidelines and in-market local regulations.  To ensure a seamless integration with our customers own QA systems and processes, we have invested in a quality management system routinely used by pharmaceutical, biotech, and medical device companies, and we are ISO9001 certified. Our QA service offering includes clinical site, protocol and clinical database audits, as well as providing support to our clients for regulatory bodies inspections.

At GenesisCare, our global team of Pharmacovigilance (PV) experts manage the safety and pharmacovigilance needs of clients throughout all stages of product development.

Our PV services for Phase I-III development include:

• SAE reporting
• SAE processing
• Narrative writing
• Medical review
• Lab and diagnostics test review
• Safety report distribution and submission
• Expertise in all major systems

Our PV team work with industry standard platforms to manage case reporting, including the TARA PV platform.

GenesisCare partners with leading biostatistics service providers, who work in close collaboration with the data management and project management teams throughout all stages of a study.

Our services include sample size estimation and review of methodology, statistical analysis, rapid data delivery, access to all compatible data formats and files, and clinical study report delivery.

We offer end-to-end clinical research communication services, built from a comprehensive understanding of in-country regulatory guidelines and scientific communication expertise.

Our medical writers work closely with other key functions, including Biostatistics, Quality Assurance, and Clinical Operations, to ensure timely and efficient information transfer.

Our medical writing services include:

• Regulatory: writing and submissions
• Clinical study protocols and amendments
• Informed consent writing 
• Publications and abstracts
• Investigator educational material
• Clinical study report writing