Clinical Monitoring
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.
Experience with both outpatient and inpatient charting.
Lotus Clinical Research monitors have experience with both outpatient and inpatient charting, including anesthetic records and surgical procedure notes. Monitors are also trained in placebo response reduction and the administration of analgesic questionnaires. Proprietary Lotus generated training tools allow them to efficiently pass this information onto site-level staff.
Quality data review.
Lotus Clinical Research’s select group of monitors dedicate themselves to providing an exceptional level of quality data review while thoroughly engaging themselves with study sites. Our monitors perform on-site clinical trial monitoring visits throughout the length of the study to oversee the collection of data; review clinical laboratory results, source documentation and electronic/paper case report forms; resolve data queries; and confirm regulatory compliance.
Specializing in analgesic research.
As a result of specializing in analgesic research since 2001, Lotus has worked repeatedly with sites that are experienced with common pain models such as: dental extraction, bunionectomy, abdominoplasty, Delayed Onset Muscle Soreness (DOMS), Opioid Induced Constipation (OIC), knee replacement, hip replacement, soft tissue surgery, chronic lower back pain, osteoarthritis, postherpetic neuralgia, and Diabetic Peripheral Neuropathy (DPN).
In order to ensure site excellence, Lotus Clinical Research continually evaluates each site’s performance, not only by tracking enrollment and assessing data quality, but also by quantifying scientific outputs. We only work with sites that have a proven track record of distinguishing efficacious drugs from placebo.
Some key analgesic site characteristics are:
- Experience with common analgesic models
- Ability to distinguish efficacious drugs from placebo
- History of reliable enrollment and Good Clinical Practice (GCP) compliance
- Training site staff and investigators on minimizing placebo response
Lotus Clinical Research provides ethics committee documentation services for sponsors. Our teams draw from extensive internal resources to provide the following services:
- Quality review of startup documents
- Essential regulatory document collection from participating clinical trial sites
- Safety reporting
- Trial Master File (TMF) services
In order to ensure structural and procedural independence is maintained between our CRO and site, monitors report directly to, and are managed by, Lotus Clinical Research CRO project managers. Our monitors:
- Are experienced in Phase I-IV clinical studies
- Provide GCP-focused data review
- Are trained/experienced in analgesic clinical trials
- Provide flexible scheduling to ensure proper on-site time
- Provide fast turnaround time for site visit reports
Ethics committee documentation services.
Lotus Clinical Research provides ethics committee documentation services for sponsors. Our teams draw from extensive internal resources to provide the following services:
- Quality review of startup documents
- Essential regulatory document collection from participating clinical trial sites
- Safety reporting
- Trial Master File (TMF) services
