Clinical Monitoring

At Lotus Clinical Research, our Clinical Research Associates (CRAs) are focused upon the two cornerstone responsibilities of Good Clinical Practice (GCP): protecting the rights and well-being of human subjects and ensuring that trial data are accurate and complete, confirming that the trial conduct is in compliance with GCP. We achieve this by hiring skilled, knowledgeable professionals with extensive clinical research hands-on experience. Our CRAs average over 10 years of industry experience. Lotus Clinical Research provides the most cost-effective solution to your monitoring needs by assigning CRAs located within the shortest travel time possible from their sites aligned with the therapeutic experience that best supports your trial objectives. Lotus Clinical Research provides extensive and complete onboarding to ensure that our CRAs have the tools and knowledge to be successful working with us. The CRAs also receive ongoing training ensuring they are up to date with current regulations, techniques, and technologies.

Quality Data Review

The CRAs at Lotus Clinical Research dedicate themselves to providing an exceptional level of quality data review. Our CRAs are assigned an average two protocols at a time which allows them to better understand and focus upon their studies. We train our CRAs to not only provide accurate source data verification, but to also review the data wholistically looking for outliers and inconsistencies that may signal a risk. Our CRAs ensure data quality by performing on-site visits as well as remote review utilizing tools designed to assess risks in each protocol. Our CRAs are all trained on and have performed various methods of monitoring including targeted, centralized, risk-based, and unblinded monitoring. Our CRAs are also proficient at reviewing PROs and patient diaries (paper and electronic), data management reports, and EDC outputs allowing them to be more efficient and effective when monitoring. Our main goal is ensuring that your data is complete and accurate and will withstand the rigors of regulatory authority scrutiny.

Therapeutic Expertise

Our CRAs are trained to manage trials at every stage, regardless of complexity. While our CRA team includes a wide range of therapeutic and study phase expertise, they have a focus on pain, CNS, and early phase development study experience.

EDS Expertise: HAP/HAL Studies, SAD/MAD studies, Renal/Hepatic Insufficiency.

Site Start-Up

Lotus Clinical Research includes an expert team of Regulatory Specialists who guide our clinical sites through the start-up process. Our team strives to reduce site burden and work efficiently with each site’s individual needs and processes to start trials as quickly as possible, sometimes in as little as six weeks.

Document Management

At Lotus Clinical Research we begin our trials with a focus on inspection readiness. Our process begins with an accurate and complete agreement on our expected documents list, effective document collection and efficient review and processing into our Veeva Vault eTMF. Our team provides transparency of eTMF health to our sponsors by providing regular reports and metrics along with direct access to the eTMF.