Quality By Design

We achieve and maintain superior standards with these 6 powerful strategies.

We ensure the highest quality through six key pillars:

1. Skillful Personnel

Our operations are led by experienced professionals within the industry.

2. Autonomous Quality Assurance Unit

Dedicated leaders report directly to the CEO, operating independently from the clinical trial teams to maintain quality.

3. Thorough Guidelines and Training Protocols

Ensuring quality through clear and strong policies and reliable assurance training.

4. Effective Quality Control and Operational Adherence

Our workforce is held responsible for compliance, which is monitored by a strong system.

5. Quality-Centric Atmosphere

Our team's complete dedication to making high-quality clinical trials accessible worldwide underpins a focus on compliance.

6. Enforcement And Responsibility

A well-established system for corrective and preventive actions (CAPA) guarantees timely resolution of detected non-conformances by investigating, correcting, and preventing the underlying causes of quality events, then verifying effectiveness.

Established Quality Assurance

As a global research site conducting numerous studies yearly, we're dedicated to quality that extends systems and tools—it's about instilling a culture where everyone owns quality. Biopharma's strong quality reputation rests on solid values, careful quality planning, and skillful execution.

To maintain our high standards, external parties regularly review our clinical research practices. Sponsors, CROs, and regulatory bodies conduct regular audits at Biopharma Informatic. We've undergone hundreds of these audits in recent years. We encourage you to explore our proven track record, affirming our practices, policies, and procedures.

Audits offer fresh perspectives, helping us in identifying and rectifying potential shortcomings while fortifying our ability to prevent them ahead.

Biopharma Informatic, conducting hundreds of studies each year, undergoes regular audits by sponsors, CROs, and regulatory bodies as part of its research activities.


of external audits, conducted by sponsors, CROs, and regulatory bodies, spanning the past 13 years


audits in just the first half of 2023

Our work reflects our high standards.

Chosen by 150+ sponsors and CROs to conduct their research

Ensuring Quality Excellence

Quality assurance at Biopharma Informatic starts with a leadership team dedicated to it. Our experts, possessing extensive and profound experience, ensure that processes are executed correctly. The Quality Assurance team plays an essential role in guaranteeing compliance with study protocols and regulatory guidelines to prioritize the safety of trial participants and maintain the integrity of generated data.

Regular internal audits, conducted every six months or as needed, include trial-specific and process evaluations. Moreover, the Quality Assurance team scrutinizes all Corrective and Preventive Actions (CAPAs), performing effectiveness checks to detect trends for further assessment and potential process enhancements.

Enforcing Operational Compliance

Our Operational Compliance Representatives (OCRs) form a crucial part of guaranteeing quality in our clinical trials, driving compliance and refining processes at our sites. They take charge of an operational framework focused on quality compliance and oversee site operations within the parameters of regulations, industry benchmarks, local laws, internal procedures, and client demands.

Their vigilant oversight ensures that each step of the trial adheres to stringent quality assurance measures, guaranteeing the integrity of data, the safety of participants, and the overall success of the study.

By conducting regular assessments and implementing necessary improvements, our OCRs contribute significantly to upholding the gold standard of quality in clinical research.