Who we are
Clinical Research and Biosciences (CRBio) is a full service clinical research organisation offering services for BA/BE studies, patient-based PK/PD endpoint studies, clinical trials, PK/statistical analysis and data management.
Our 114 dedicated clinical pharmacology beds—with two fully functional ICUs (3 beds each)—tandem LC‑MS capability and partner network let us stay accountable end-to-end while still moving quickly.
In clinical research time is critical—we are committed to quality services within the agreed timeline.
The CRBIO Values
Compliance
At CRBio, every study is conducted in accordance with applicable national and international regulatory requirements, Good Clinical Practice (GCP), Good Laboratory Practice (GLP). Our robust Quality Management System ensures that processes are standardized, documented, monitored, and continuously improved.
Reliability
At CRBio, we consistently deliver studies with scientific precision, operational discipline, and predictable timelines. Our experienced multidisciplinary team works collaboratively to ensure every project is executed with accuracy, transparency, and attention to detail.
Built on Quality
At CRBio, every procedure, workflow, and analytical method is developed using risk-based planning, standardized operating procedures, and rigorous quality controls. Our philosophy of "Quality by Design" ensures that every activity contributes to reliable data, regulatory confidence, and successful study outcomes.
Integrity
CRBio is committed to maintaining the highest standards of ethical conduct and data integrity. We foster a culture of honesty, accountability, and transparency where scientific decisions are based on reliable evidence and every member of our team understands their responsibility in protecting data integrity.
Operational Excellence
CRBio combines scientific expertise with disciplined project management and continuous improvement to deliver efficient, high-quality studies. Through optimized workflows, integrated teams, and a proactive approach to problem-solving, we consistently achieve reliable outcomes without compromising quality or compliance.
Regulatory submissions
1000+ BA/BE studies completed and submitted across major regulatory bodies.
Agencies represented in programmes include CDSCO India, US FDA, Health Canada, EMA, MHRA, WHO, Ministry of Health (Turkey), TGA Australia, Malaysian pharmaceutical oversight —and other national authorities.
Regulators & jurisdictions
Individual marks remain the property of each agency—shown here to illustrate historical submission geographies.
Operational philosophy
Methodical vigilance across clinical, bioanalytical and data streams—transparent interfaces, inspection-aware documentation, and leadership that can escalate science without unnecessary bureaucracy.
Strategic partners worldwide
Through our strategic partners across the globe, we extend our reach into preclinical work, early- to late-phase bioanalysis (LC‑MS), regulatory support, pharmacovigilance and medical writing. Partners bring extensive experience into their disciplines and give us flexibility to offer a full basket of services. All collaborative laboratories are US FDA approved.
Capability
Our strength and expertise
We assure high-throughput sample analysis and quick turnaround times for challenging molecules. Our team blends young energy with deep domain expertise and regulatory judgement.
The library now spans 300+ validated methods—from simple and simultaneous assays through ultra-low LLOQ work, chiral and derivatisation strategies, and speciality matrices.
Experience footprint
- Studies on controlled substances
- Psychotropic substances
- Post-menopausal female cohorts
- Hormonal drugs
- Patch studies
- 505(b)(2) pathway
- First-to-file experience
- PD study experience (Orlistat)
- PK endpoint studies — azathioprine, nevirapine, temozolomide, clozapine, capecitabine
Explore how we structure programmes—or reach the BD desk for an introductory call.