Frequently Asked Questions

The following are questions most frequently asked by our clients. If your question is not listed, please contact us for further information or clarification.

For smaller studies LBR uses employee CRAs. For larger studies it hires contract monitors to augment the team. The company maintains a group of contract CRAs who have long-standing contracts (>5 yrs) and function as employees for the duration of the project. This ensures that all monitors are committed to the study full time and facilitates consistent monitoring across all sites. Additionally, LBR co-monitors as a further step towards study-wide consistency and quality.

LBR believes that a smaller number of experienced staff can deliver a higher-quality product than larger number of lesser-experienced staff. This commitment to hands-on work by the most experienced staff has allowed the company to significantly reduce overhead associated with staff who merely manage the work of others.

As a non-public company, LBR does not have the pressure to meet stockholder and analyst expectations for profits beyond those required to provide reasonable financial compensation to its employees. The results of these financial efficiencies are reflected in responsible pricing without having to sacrifice quality.

The answer is simple. We hire only experienced people, and then give them the luxury of spending the day working on projects without the distraction of endless meetings and the background noise of corporate politics.

LBR has qualified preferred vendors it uses for data management and biometrics.

Yes, the company has extensive experience in selecting and managing vendors, including IVRS providers, Clinical Laboratory providers, ECG central readers, PK laboratories, BMD central readers, Central IRBs and others.

LBR has remained small to assure hands-on involvement in projects by our most experienced employees. We will not take on a project if there is not sufficient experienced staff to execute the project.

LBR maintains a network of individuals and other small companies that deliver quality work with which we contract on a project-by-project basis. These include individuals with expertise in PK, Toxicology, GMP issues, etc.

LBR has extensive experience in many major therapeutic areas. The company has also worked on many rare and orphan specialty indications that required an innovative operational ability to organize a complex set of outcome measures.

When a new or unusual therapeutic indication arises, LBR can successfully use both its strategic regulatory consulting and project management skills to craft a development strategy to suit. Part of this strategy is to leverage the relationships the company has with FDA Reviewing Divisions. Having contacts in the FDA provides an avenue to obtain input quickly.

For project management, LBR focuses on execution to meet sponsor expectations and FDA requirements. The company has worked on many projects in which personnel do not have direct therapeutic experience yet has completed these projects with high-quality data and cleared Agency reviews.

LBR has the expertise and experience to conduct inspection ready visits. The company has conducted these types of visits in the US, Canada, South America, Eastern and Western Europe.

LBR’s approach to inspection ready visits is to: 1) train the sites in what to expect from the FDA Investigator; 2) instruct sites on how to address questions from the FDA; 3) completely review the documentation at the site; and 4) alert the site staff to issues that might require the PI to address during a Regulatory Audit. The sites prepared for FDA Investigations are comfortable with these audit and feel adequately prepared.