Expertise
Early Clinical Development
Over the last decade, India has cemented its position as one of the best countries to conduct early phase studies. As the need for advancing assets in development continues to increase in pharmaceutical and biotechnology companies, India has become a preferred destination to help drug developing companies generate early human clinical data and reach the go/no-go decisions faster. India is well known for its world-class research and healthcare infrastructure. In addition, there are modern, high quality dedicated early phase clinical trial units across India that are very experienced in delivering all types of early human clinical studies including Proof of concept studies, first in human studies, early clinical studies with intensive PK/PD assessments, Bioequivalence and Bioavailability studies, biosimilar studies and early phase clinical studies that require special patient populations.
Clinhealth has access to over 300 dedicated early phase clinical beds in India across five major cities. In addition, Clinhealth has access to investigator led sites and site networks in most major healthcare facilities across India for conducting early phase studies in the hospital setting. We also maintain deep relationships with Key Opinion Leaders and engage them for our studies as per need. To achieve the highest data quality and meet recruitment needs of early phase studies, we work as a partner with the drug development company to establish the best plan for conducting the early phase clinical study in India.
The success of early phase clinical studies in India has been a result of a concerted approach by various stakeholders to allow for an easy, safe and highly compliant environment for early phase studies to come to India.
Oncology CRO Solutions in INDIA
Oncology clinical trials require significantly robust support from start to end from your CRO partner. In contrast to other therapeutic areas, oncology poses special challenges when it comes to selecting the right investigator sites, laboratories, imaging facilities, and study teams. A fail-safe implementation strategy is critical for the success of each oncology clinical trial across the different phases of the clinical development process. We work closely with our clients to fully understand the unique needs of their development process. The needs of a biotechnology company that requires the securing of further investment or out-licensing the asset can be different from a mid-size or large pharmaceutical company developing their oncology drug.
Clinhealth team has deep experience in planning and implementation of complex oncology studies. We have experience in multiple areas within oncology including immune-oncology studies. For each oncology study, we ensure that the Project Manager (PM) and Site Monitors have extensive experience in oncology studies, and especially in the indication that the specific study is focused.
For early phase oncology studies, Clinhealth ensures that we stay time-critical for all aspects of the studies so that our clients are able to reach their study milestones earlier than expected or on time as per their plans. We do this through a concerted team work across our clinical project team for the study. We work with dedicated facilities or very experienced oncology centres that have shown past success in conducting early phase oncology studies. With the support of our technology platforms for EDC and Data visualization, we area able to be nimble and resourceful for speedy start-up and efficient recruitment for oncology studies.
Companion Diagnostics
Clinhealth has expertise and our team has experience in supporting In Virto Diagnostics companies to develop their diagnostic products. Clinhealth also has in-house Companion Diagnostics, Principal Investigator experience.
At Clinhealth, we understand the complex regulatory and operational challenges to implement IVD and CDx studies. Our team has the expertise and experience to work as a team with the laboratories, pharmaceutical partners and IVD companies to bring diagnostic studies together. Based on the client’s requirements of utilizing a laboratory that does or does not operate under an accredited environment, Clinhealth utilizes its network of commercial and research institutes-based laboratories in India to deploy diagnostic studies.
Our team has the necessary expertise to support the development of the biomarker strategy for a drug asset in development and the development of regulatory compliant CDx development plan.