The following are questions frequently asked by our clients. If your question is not listed, please contact us for further information or clarification.
For smaller studies LBR uses its own employees, including director level, who have been trained as monitors to meet the monitoring needs. For larger studies LBR hires contract monitors as LBR employees for the duration of the project to augment the LBR staff. This assures that all the monitors are committed to the study full time and enables LBR to deliver consistent monitoring across all sites. In addition, senior LBR staff co-monitor as a further step towards study wide consistency and quality.
LBR was founded with the philosophy that the experienced employees should be performing tasks and providing services to the customer and not merely managing other employees. LBR was also founded on the belief that a smaller number of experienced staff could deliver a higher quality product than a large number of lesser experienced staff. This commitment to hands on work by the most experienced staff has allowed LBR to significantly reduce the overhead associated with staff that only manages the work of others. LBR has also kept other overhead positions to a minimum. As a non-public company LBR does not have the pressure to meet stockholder and analyst expectation for profits beyond that required to provide reasonable financial compensation to its employees. The results of these financial efficiencies are reflected in LBR's rates.
The answer is simple. LBR hires only experienced people and then we give them the luxury of spending most of the day working on projects without the distraction of endless meetings and the background noise of corporate politics.
LBR does not provide data management or statistical services as these areas are not ones in which we have the required expertise. LBR has interfaced with data management and statistical providers on many projects. LBR has experience in selecting and managing data management and statistics vendors and in working with these vendors when they are selected and managed by the Sponsor
Yes, LBR has experience in selecting and managing other vendors, including IVRS providers, Clinical Laboratory providers, ECG central readers, PK laboratories, BMD central readers, Central IRBs and others.
LBR has remained small in order to assure hands on involvement in projects by the most experienced employees. As part of this business strategy LBR will not take on a project if there are not sufficient experienced staff to execute the project.
LBR has a network of individuals and other small companies that deliver quality work with whom LBR contracts on a project by project basis. These include individuals with expertise in PK, Toxicology, GMP issues and others.
Due to a lack of marketing creativity we simply chose to use Lois's initials for the company name.
We have been able to be successful in therapeutic areas we have not had experience in because in both strategic regulatory consulting and project management our skills are based on knowledge of FDA expectations and requirements which transcend across therapeutic areas. Our focus is on meeting FDA/EMEA expectations for execution of studies to achieve high quality data. We also have experience in most of the FDA Reviewing Divisions which helps us to be able to work with our customers in therapeutic areas we may not have direct experience. Having contacts in the FDA provides us an avenue to obtain input quickly. For project management, we focus on the execution of the protocol to meet sponsor expectations and to meet FDA requirements. LBR has worked in many areas that personnel do not have direct therapeutic experience and have successfully seen the project to completion with high quality data and no issues following Agency review.
LBR has the expertise and experience to conduct these types of visits. LBR has conducted these types of visits in the US, Canada, South America, Eastern and Western Europe. LBR's approach to these types of visits is to 1) train the sites in what to expect from the FDA Investigator; 2) how to address questions from the FDA; and 3) completely review the documentation at the site and alert the site staff to issues that might require the PI to address during a Regulatory Audit. The sites that we have gotten ready for FDA Investigations have been comfortable with the audit and are prepared.