Clinical Monitoring Services
Expert Clinical Monitoring: Built for Data Integrity and Patient Safety
High-quality monitoring is the foundation of every successful clinical trial. At Lotus, clinical monitoring is performed by highly skilled professionals, combining deep therapeutic expertise with a commitment to protecting patients and ensuring data integrity.
Why Choose Lotus
Experienced
CRAs
10+ years average industry expertise across all phases
Manageable workload
Our CRAs manage an average of just two protocols at a time
Cost-Efficient Coverage
Always
Inspection-Ready
Full transparency via Veeva Vault eTMF and CTMS
Flexible Monitoring Strategies
Full SDV, targeted SDV, and customized strategies
Our Approach:
- We hire experienced and accomplished CRAs, and invest heavily in training and onboarding so that every CRA has the tools, regulatory knowledge, and ongoing education needed to deliver high-quality monitoring throughout your study.
- Each CRA is carefully aligned to sites based on therapeutic expertise, proximity, and workload, ensuring cost efficiency without compromising quality.
- Our team-based approach means each site has a primary CRA and a designated backup CRA to guarantee consistency and coverage. CRAs work closely with Clinical Trial Managers (CTMs) and Project Managers, ensuring seamless coordination across site start-up, monitoring, and Trial Master File management.
- Between visits, CRAs maintain ongoing communication with sites, tracking enrollment, data entry, query resolution, and regulatory updates. All reports and documentation are managed in Veeva CTMS and Veeva Vault eTMF, giving sponsors full transparency and optional access to review.
Experience Spans Therapeutic Areas, Phases, & Trial Designs
Our CRAs are deeply experienced in key therapeutic areas, across all phases and trial designs.
Rare/Genetic Diseases
Infectious Disease
Pediatrics
Medical Devices
Early Clinical Development Expertise
- Human Abuse Potential (HAP) / Human Abuse Liability (HAL) studies
- SAD/MAD studies
- Renal/hepatic insufficiency studies
Our team ensures high-quality data and efficient execution, helping Sponsors move confidently into later trial phases.
How We Monitor
Monitoring activities are outlined in a customized Monitoring Plan developed at study start, with Sponsor review and approval. Our services include:
Feasibility & Site Selection
Site Initiation
Interim Monitoring
Close-Out Visits
Unblinded Monitoring
Data Review
Lotus CRAs dedicate significant time to quality data oversight. By managing an average of just two protocols at once, CRAs gain an in-depth understanding of each study.
Our data review includes:
- Source data verification and holistic review to identify risks, inconsistencies, or outliers
- On-site and remote monitoring using advanced risk assessment tools
- Proficiency in targeted, conditional, centralized, risk-based, and unblinded monitoring
- Review of PROs, patient diaries, data management reports, and EDC outputs
Our priority is ensuring your data are complete, accurate, and ready to withstand regulatory scrutiny.
Site Start-Up Services
Our Regulatory Specialists accelerate site activation with a collaborative, workflow-sensitive approach. By minimizing administrative burden, we can often activate sites in as little as six weeks. From initial contact to full activation, we ensure sites are supported every step of the way.
Document Management & Inspection Readiness
Inspection readiness begins on day one. Our process includes:
- A mutually agreed document list at study start
- Efficient collection and thorough review of all essential documents
- Integration into our Veeva Vault eTMF system
Sponsors have real-time transparency through regular reports, performance metrics, and direct eTMF access, ensuring confidence in compliance and oversight.