Our Services

Comprehensive clinical research services designed to accelerate your drug development journey from concept to market approval.

FDA
FDA Inspected
DCGI Approved
GCP
GCP/GLP Standards

Explore Our Complete Methods List

Request our comprehensive list of available methods and capabilities.

Clinical Pharmacology Services

ZenRise is a GCP-compliant DCGI (Drug Controller General of India) approved facility staffed by an experienced team of medical professionals and supported by a team of clinical investigators, physicians, an operations manager, clinical study coordinators, pharmacists, and freezer custodians. A well-equipped ICU with all the necessary infrastructure supports 123 beds for all clinical pharmacology studies.

BA/BE studies: Fasting/Fed/Applesauce
Drug interaction studies
Food effect studies
Dose-proportionate studies
Multiple-dose studies
Clinical Pharmacology Services Facility
BioAnalytical Services Laboratory

BioAnalytical Services

ZenRise is a GLP-compliant bioanalytical laboratory equipped with the most advanced LC-MS/MS systems for carrying out method development, validation, and regulated sample bioanalysis. ZenRise supports a sample preparation laboratory equipped with all typical laboratory equipment necessary for all bioanalysis work. ZenRise has labs that have all SOPs and systems to support bioanalytical studies for DCGI, FDA, MHRA, and EMEA. The team has in-depth expertise in recent regulations and inspections.

Method development
Method validation
Regulated sample analysis

Clinical Trials

ZenRise has expertise in designing and conducting pharmacokinetic-based studies for demonstration of bioequivalence in patients. ZenRise has the capability of conducting multi-center patient-based clinical efficacy/therapeutic endpoint studies. ZenRise can also plan and execute from a small proof-of-concept study to a large multi-center study.

Patient-based PK and BA/BE studies
Therapeutic endpoint studies / Efficacy studies
PMS Studies
Clinical Trials Research
Clinical and Bio-Analytical Monitoring

Clinical and Bio-Analytical Monitoring

As a standalone service, ZenRise offers the following independent study monitoring services to prospective clients.

Monitoring services for studies conducted at BA/BE study Centers
Monitoring at Bioanalytical laboratories

Protocol Development and Medical Writing

As a standalone service, we will assist you in the design and development of the most innovative protocols to get more information from a smaller study. Our team has more than 20 years of experience in protocol development and medical writing.

Design and develop a protocol for the intended regulatory country
Provide regulatory services
Medical writing expertise
e-CTD and CDISC services
Protocol Development and Medical Writing
QA and Auditing Services

QA and Auditing Services

Independent quality assurance function reporting to management for all in-house Clinical and Bioanalytical studies. ZenRise can offer audits of other CROs specific to all clinical and bioanalytical areas.

Third-party auditing: On behalf of the sponsor, ZenRise can undertake third-party auditing with due diligence
Qualification of laboratories: Can audit and qualify laboratories for suitability for conducting studies