About LBR
LBR was founded in 2001 by Lois B. Rosenberger, Ph.D. on the belief that a team of experienced professionals, who were driven by a hands-on work ethic and unencumbered by the administrative processes of a larger company, could deliver higher-quality regulatory and clinical services in a more cost-effective manner.
Since 2001, the company has held true to this basic principle, and this dedication has been rewarded with a steady flow of repeat business from satisfied clients and subsequent referrals.
As a boutique CRO, LBR provides quality end-to-end services including a broad range of regulatory services for running and managing all aspects of clinical research trials. The company maintains a large client base of pharmaceutical companies of all sizes: from start-up and small companies to medium-sized drug, device and biotech companies who lack in-house resources. LBR clients also include large pharmaceutical companies that require extended capabilities due to a shortage of in-house expertise.
Clients receive the advantage of a specialized array of regulatory and clinical services in a framework that allows a tailored, cafeteria-style approach. This concept allows small to mid-size companies to reap the benefits associated with in-house regulatory compliance and clinical project management expertise without the long-term overhead commitments.
- Expert Services for Pharmaceutical and Biotechnology Companies
- LBR’s client base includes emerging to moderate-sized Pharmaceutical and Biotechnology companies, with project sizes ranging from single-site studies to large pivotal NDAs to broad regulatory consulting.
- For smaller clients, LBR’s team of experts provides a way to control costs without forsaking critical regulatory and clinical operation services. Such clients are routinely provided with de facto regulatory, clinical project management, monitoring, and compliance as needed.
- For larger companies, LBR provides a ready source of experienced professionals who can augment in-house personnel to meet peak workload demands. This affords our clients rapid response options to meet temporary workflow peaks without increasing in‑house resources.
- LBR’s high level of employee satisfaction is a result of the company’s long-term employee retention. An unusually low turnover rate provides clients with consistent team stability and project continuity. Every project is staffed with the most qualified and experienced personnel available.
Quality Results-Driven Philosophy
LBR’s uncompromising quality and results-driven philosophy is evidenced by its track record of FDA approvals. Some examples include:
- Myfembree | Myovant
- Imvexxy Vaginal Inserts | TherapeuticsMD
- Bijuva Capsules | TherapeuticsMD
- Lysteda | Xanodyne/Ferring Pharmaceuticals
- SABER Equine Ovulation Inducer | Thorn BioScience
LBR recognizes the importance of every project to the client and will only take on new projects if doing so will not compromise the staffing or quality of ongoing projects.
Our Philosophy
The name LBR is synonymous with quality and superior client satisfaction. Most of our work originates from repeat business and customer referrals.
The company’s mission is to provide high-quality clinical services that are tailored to meet each client’s individual needs. To ensure its hallmark of quality results and individualized client attention, LBR does not take on more work than can be comfortably managed.
Accomplishments
Since our founding, LBR has:
- Provided Project Management and Clinical Services for five NDAs that received FDA approval
- Provided end-to-end CRO services for numerous clinical studies
- Served as the FDA liaison for more than 20 Sponsors
- Made more than 2,000 regulatory submissions
- Provided strategic Regulatory Consulting for preclinical, clinical, and manufacturing for more than 40 Sponsor companies.
- Maintained multiple TMFs
Awards
- Winner of the SUCCESS Award, the Northern Kentucky Chamber of Commerce’s top business award for professional services, June 2005
