“BIA Clinical provided monitoring oversight services for 4 large, global Phase 3 programs and did a fantastic job! They came in and quickly analyzed the current state, and then focused on areas needing additional support/remediation. They conducted monitoring oversight visits and worked directly with us and the CRO staff to resolve some very significant challenges. Their staff are seasoned professionals and worked seamlessly with our staff. We extended their services to provide support for regulatory agency inspections at clinical sites and the sponsor inspection. Again, they did a fantastic job! Their staff assisted in the preparation activities, including the management of a Trial Master File health check with the CRO. The successful outcomes we had would not have been possible without this incredible group of people!”
TESTIMONIALS
- Senior Director, Monitoring
“I had the distinct pleasure to work with the BIA team, in particular their Data Management group. They are an extremely talented and dedicated group who worked with diligence, transparency, and an impressively positive attitude. They provided data review support and took the time to look at the situation and make thoughtful and insightful recommendations on additional ways took look at the data to ensure the utmost data integrity. The BIA DM group created concrete plans, communicated them effectively and carried them out methodically. The team provided regular updates, and always escalated any issues or unusual observations immediately. I also had the opportunity to interact with BIA in other capacities, in particular inspection readiness and TMF teams and was equally impressed. I would welcome the chance to work with BIA again and would recommend them highly.”
- Director of Clinical Data Management
“When engaging a contract organization, one always runs the risk of the company you contract with just doing the job to meet the minimal criteria however the BIA Clinical Group is different in that respect. The team are staffed with highly skilled professionals that are collaborative, knowledgeable, engaged, and industrious. Work was always high quality and on time and it felt like they genuinely cared about providing the very best expertise and service; like the program was theirs. With their expertise we were able to successfully identify and remediate areas that raised concerns. Their involvement directly impacted our submission quality. I think the staff expertise and engagement were what drove the success of the project; under another group I don’t feel that we would have had the same level of engagement or outcome. I have witnessed BIA involvement in activities since 2019; clearly the team knows the drug development process and what ‘good looks like’ and because of that our company was able to devote time and energy into areas where there was substantial return on the investment, contributing to the program’s overall success. It has been an exceptional experience to have worked with this team.”
- Senior Director of Research Quality Assurance
“Our company, specifically Clinical Operations and Data Sciences, has been working with BIA personnel since 2018 (over 3 years). As a small biopharma company we recognized the need to augment our teams and their expertise and were able to do that with much help from BIA. The level of experience, expertise and dedication that BIA provided is unmatched. In a competitive landscape such as this it is so difficult to find the right people but BIA didn’t miss a step. The seasoned professionals assigned to our program to ensure our team was executing at the top level made a dramatic and impressive difference. No matter what the ask was (data review, monitoring oversight, Important Protocol Deviations, Trial Master File health check, Inspection readiness and BIMO work) they came prepared, knowledgeable and ready to work. The BIA members were there to supplement our existing staff but integrated and all became a cohesive and seamless operating team. It has been both a pleasure and privilege to work with the Principal members and their staff on a business critical project. I know that the working relationship is one that the entire company has valued and BIA is considered a trusted partner now and for the future.”
- Vice President, Clinical Operations
“In my consulting of preparing an organization for GCP Pre-Approval Inspection, I had the opportunity to work closely with the BIA Clinical Group on a number of activities related to Inspection Readiness as well as aspects of the NDA, specifically BIMO Listings and Financial Disclosure 3454 and 3455 preparatory documents. I was impressed with the BIA Clinical Group leaders and team as a whole, for their contributions during the study conduct and in preparing for Inspection readiness.”
A few stand out points:
- High knowledge base of clinical study conduct, translates into solid solution approach.
- The ability to distill a massive amount of information into understandable metrics and actionable plans. TMF Health Check, Monitoring Oversight and Important Protocol Deviations.
- They pay very close attention to the details, cross-checking and QC’ing any documents they prepared, that installed a high confidence in their work product. This was important in reconciling 1572 forms with Financial Disclosure documents and site contact information to support NDA documents of BIMO listings and Financial Disclosure 3454 and 3455 Forms and supporting documentation.
- They are also a nice, collaborative and dependable group to work with.
- Consulting GCP Pre-Approval Inspector
“The BIA Clinical Group has supported our phase 3 clinical program for almost 4 years. Their team members and leadership are highly experienced, flexible and collaborative. Recently they played a critical role in our inspection readiness program and the subsequent management of a successful FDA GCP sponsor inspection.”
- Senior Vice President, Clinical Operations and Data Science