Clinical Trial Audit and Monitoring Services
Clinical Trial Audit and Monitoring Services
Our well-trained clinical research associates (CRAs) are highly trained professionals who ensure the integrity of the study and committed to excellence
Efficient monitoring of Clinical sites from Site Qualification to Report generation
Pepgra offers risk-based high-quality services in clinical trial monitoring, that ensures scientific excellence and data integrity across operational centres and regional hubs. Our in-house project management and operations team travel across the globe to support the project team, by leveraging local knowledge of the regulatory environment. Our clinical research associate team, who are aware of local laws, regulations and guidelines will work with you on-site as part of your team – they bring the commitment, passion and motivation to maximize the potential of everyone.
We offer a remote monitoring solution that can be delivered to our customers, which would reduce the frequency of on-site visits and enhance data quality. Our experts ensure that there is perfect coordination among clinical research associates, project managers, sponsors, and clinical trial sites.
Pepgra CRO rigorously scrutinizes its CMD services and projects in terms of the teams involved in them and resources used with the aim to ensure details of every project are strictly kept within its operational zone. By providing our clients with the most sophisticated services in CDM, we have transcended the conventional model. We continue to strive to take CMD services to even greater heights.
Comprehensive Clinical Trial Monitoring Solutions
A partnership
built on trust
Find out how our people, processes and culture of quality come together to make sure that work flows smoothly and consistently, always.
A partnership
built on trust
Find out how our people, processes and culture of quality come together to make sure that work flows smoothly and consistently, always.
A partnership
built on trust
Find out how our people, processes and culture of quality come together to make sure that work flows smoothly and consistently, always.BBA has extensive experience with a variety of medical device clinical trials and programs, including PMA and 510(k) studies and studies of therapeutic, diagnostic and surgical devices. Recent successes include enhancing studies through adaptive and Bayesian design resulting in decreased trial duration and early product approval.
We deliver study designs balanced to meet your business needs and expectations with the current scientific understanding and all regulatory requirements considered.
Allow us to help propel your product forward.
The Boston Biomedical Associates team was instrumental in their support of AtriCure in executing our ABLATE trial, interacting with the FDA and preparing for the panel meeting. We are impressed with their extensive clinical and regulatory expertise as well as their professionalism and appreciate their support in working with us to achieve a positive panel vote.
— David J. Drachman, Former President and Chief Executive Officer of AtriCure, Inc.
The agility to
grow with your needs
Our process, technology solutions and culture of excellence give us the ability to scale up
without compromising on quality
Supporting you
through the entire product lifecycle
From study design to post marketing surveillance and commercialization support.
Safety and Risk Management capabilities brochure
Sciformix’s Integrated Drug Safety solution seamlessly interweaves and synchronizes case processing (ICSR), aggregate reporting (PSUR, PADER, PBRER, ASR) and risk management across all phases of the product lifecycle. Our scientific experts aggregate and evaluate safety information from all sources, including individual cases, published safety data and competitive products to facilitate evidence-based proactive drug safety decisions.
Download information on our Safety and Risk Management services. (PDF)