Clinical Research

The Philosophy of Rasayani Biologics believes firmly in capturing the Clinical Data in a most Scientific, Ethical and In Line with Global Regulatory requirements. This data forms the basis for obtaining the regulatory approvals and also in strategizing the product segmentation.

Majority of the drug candidates at RBPL are based on reverse pharmacology approach considerably reducing the risks in the later stages of drug development. This approach helps in reducing the overall time and resources required for taking the drug from Research to the market.

EFFECTIVE CLINICAL NEEDS

Finding effective clinical needs require procedures and systems to effectively capture the clinical data of safety and efficacy from large pool of Patients

BEDSIDE-TO-BENCH APPROACH

These needs are then transformed using Bedside-to-Bench approach to effectively standardize, establish and confirm using battery of Pre-Clinical studies to support the scientific rationale of the compound. After establishing proof of concept, the drugs then undergo Clinical Trials as per respective regulatory guidelines

ENTIRE TRASFORMATIVE ACTIVITY

This entire trasformative activity needs a strong collaboration between the Physicians, the Pre-Clinical Scientists of varied Disciplines and Clinical Researchers

Clinical Research

Our clinical research department comprises a team of Physicians and Clinical Research professionals who work in collaboration with the scientists to confirm the leads.

 A team of scientists trained in clinical pharmacology, practicing oncologists/Clinicians, subject matter experts, statisticians and regulatory experts help in designing the most suitable/optimum/feasible/ practically feasible protocol, which helps in smooth and successful conduct of the study. The implementation or conduct of the study is done by a team of experienced and qualified pharmacist, Clinical Research Professionals and statisticians in compliance to applicable Regulatory Guidelines and Good Clinical Practices (GCP). Company also has collaborations with several CROs whose help is taken on a case-to-case basis.

Team of Highly Experienced and Qualified Consultants

Besides this, RBPL has a team of highly experienced and qualified consultants which plays an important role in designing right development strategy who is critical to the positioning of the molecule.

Expanding the Horizon of Partnerships

RBPL firmly believes in expanding the horizon of partnerships through mutually beneficial associations and has multiple associations with reputed Cancer Hospitals, Clinicians, Contract Research Organizations, etc. in this field to effectively offer one stop solution to the need.

Besides conducting Clinical Studies on in-house compounds, Rasayani Biologics is open to offer its expertise in the complete spectrum of Clinical Research including conduct of Clinical Trials.