Therapeutic Depth & Versatility
Navigating diverse therapeutic pathways. We combine standard regulatory structures with dedicated, specialized clinical knowledge in both modern pharmacology and traditional holistic healing systems.
Ayurveda, Biotech, and Device Experience
Xplora holds an industry-leading position by combining traditional AYUSH clinical trial execution with modern pharmaceutical and device validation protocols.
Ayurveda
India’s traditional system of medicine requires rigorous scientific validation to meet international export and integration standards. Xplora designs clinical protocols for Ayurvedic herbs and complex polyherbal formulations. We monitor patient-reported outcomes alongside objective biochemical, metabolic, and imaging endpoints to validate safety and efficacy under Ministry of AYUSH regulations.
Biosimilars
Validating complex biological molecules requires precise pharmacokinetic, pharmacodynamic, and immunogenicity profiling. Xplora assists sponsors in conducting comparative biosimilar trials, verifying similarity to reference drugs in specialized bioanalytical laboratories, and navigating compliance pathways outlined by India’s Review Committee on Genetic Manipulation (RCGM) and the CDSCO.
Herbal Medications
Phytomedicines present unique challenges in standardization, batch consistency, and compound identification. Our clinical trials integrate standardized botanical profiles with analytical batch verification. We manage safety screenings, phase-wise efficacy trials, and stability-linked efficacy checks to translate age-old herbal formulations into evidence-based therapies.
Homeopathy
Xplora executes structured clinical evaluation protocols for homeopathic preparations. We apply validated disease severity indices and clinical markers, ensuring that homeopathic studies are documented with modern statistical rigor, helping sponsors compile scientific files for regulatory reviews and clinical publications.
Medical Devices
Navigating the Indian Medical Device Rules (IMDR) 2017 demands detailed validation strategies. Xplora conducts clinical performance evaluations and usability studies for diagnostic equipment, surgical implants, software-as-a-medical-device (SaMD), and therapeutic hardware (Classes A, B, C, D). We oversee investigator training, device log compliance, and safety mapping.
Nutraceuticals
Functional foods, health supplements, and fortified dietary systems must establish clear scientific proof to support marketing claims and label representations. Xplora manages trials evaluating nutrient absorption, metabolic impacts, safety parameters, and structure-function endpoints, supporting compliant marketing under FSSAI (India) regulations.
Unani
Xplora applies modern clinical trial methodologies to evaluate traditional Unani therapeutics. By monitoring patient-reported safety and therapeutic endpoints, we help establish the safety profile and efficacy margins of traditional preparations, allowing sponsors to qualify Unani formulas for scientific registries.
Post Marketing Surveillance (PMS)
Phase IV monitoring and post-marketing surveillance are key to detecting rare adverse events, confirming drug safety in large patient populations, and gathering real-world evidence (RWE). Xplora designs and manages large-scale registry studies, patient support programs, and pharmacovigilance logging to support drug compliance and safety records.
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Ready to initiate an AYUSH or Device trial?
Connect with our therapeutic area managers in Wilson Garden, Bengaluru to review sample clinical protocols and historical trial data.
Email: info@xplorahealth.com