Clinical Development
Service Offerings
Our clinical trial head and managers provide leadership and operational expertise through collaborative planning, implementation, and execution. Our competent team of clinical research associates work closely with your team on protocol and indication training, building strong site relationships, and ensuring site compliance.
The services that we offer under clinical operations includes project management, site management, clinical trial supply management and vendor management for the below listed types of studies:
- Phase I, II & III Studies
- Patient Pharmokinetics Studies
- Devices and Diagnostics
- Post Market Surveillance (PMS)
- Non-interventional Studies (NIS)
As part of this service portfolio, we provide the entire gamut of project and site management:
- Pre-study planning and feasibility, optimum patient recruitment, site-specific guidance, proactive ethics committee managements
- Stable, effective and mutually beneficial working relationships with investigative site
- Up-to-date database of highly skilled, experienced clinicians and researchers with large patient population & genetic diversity
- Proactive patient recruitment support systems to bolster local sites' own efforts
Another of our strengths is our data-focused expertise as a ‘Biometric Clinical Research Organization’. Our primary focus is the management, analysis and reporting of data from clinical trials and post-marketing surveillance. As established experts, NBR provides our sponsors high quality support teams that offer efficient outsourcing solutions for the following deliverables/services:
- Data management
- Medical and Scientific writing
- Biostatistics
- Pharmacovigilance
With respect to the above services and deliverables, NBR can offer a wide spectrum of capabilities from the elementary study-level support to the more comprehensive and complete strategic full data-services solutions. Furthermore,through our fine quality and value-added customized solutions, we guarantee to meet all your current and future study and development needs.
The process of the launch of a new product right from its conceptualization unto its approval and use can be a lengthy and expensive process. This process would also involve clinical development and submission. Whatever be the nature of the new product – a drug, a nutraceutical, et cetera, at NBR, we understand the fine nuances and intricacies of regulatory requirements. We have the necessary resources and proven expertise to address your specific needs, immaterial of the country.
Our team of experts can support you through the entire process of clinical development, whether it is preparing the IND or IDE, providing regulatory services throughout each study, or preparing the NDA, BLA, MAA, or PMA.
Under the spectrum of regulatory services, we provide,
- Dossiers preparation
- Reports
- Consulting Services