Clinical research
Medical research provides the bedrock for evidence-based practice. Clinical studies/trials provide strongest evidence of what will and what will not work.
We provide end to end research services for drug and medical device development. These services include clinical operations support, medical writing, and regulatory consultation.
We work with individual medical practitioners, research organizations, pharmaceutical and medical device companies in development and conduct of clinical trials. Manging clinical trials to ensure studies meet GCP and Regulatory compliances.
Over the years we have supported hospitals and medical practitioners in setting up research facilities. This includes development of customized Standard Operating Procedures, guidance on research infrastructure, setting up of Ethics Committees (IEC)/ Institutional Review Boards (IRB) and training on research methodology, Good Clinical Practice (GCP) Guidelines and regulations.
Quality management in clinical research:
Research is a highly regulated field. A high benchmark is placed on research stakeholders in order to ensure rights, safety and wellbeing of human participants coupled with ensuring reliability of data.
Processes in research are driven by ‘Quality by design’ i.e. every aspect of research from concept to final report stage has to be driven by quality systems. This includes robust SOP’s, good documentation, and scrutiny of records by audits and inspections.
With our experience and expertise, we help research establishments conform to the high-quality requirements.
We do this by helping develop SOP’s that are easy to use and which allow easy work-flow management.
Our team has good experience in regulatory inspections, independent audits. We can help you prepare sites for GCP and Quality audits and inspections.
Patient recruitment and engagement:
For clinical trials to be successful, human participation as volunteers is important. However increasingly, patient/participant enrolment in clinical studies is becoming difficult. There is a need for providing accurate information to patients, caregivers and medical fraternity on the benefits and risks of clinical trials.
Our mission is to engage all stakeholders in research to provide the most accurate information in ways that are simple and easy to understand.
We aim to do this by creating an ecosystem where stakeholders come together to contribute to strategies for patient recruitment and engagement. We develop visual tools and aids for research campaigns, patient recruitment in clinical trials and informed consent.
