CLINICAL SERVICES

From Strategy to Study Close-Out. Comprehensive Clinical Excellence at Every Step​

​

With 30+ years of global clinical operations and regulatory expertise, the Landrich Group provides strategic and hands-on support to guide your Phase I through IV studies from concept to completion. We help you navigate clinical trial planning, vendor and site oversight, and day-to-day execution while staying aligned with GCP principles, sponsor responsibilities, and global regulatory expectations. Whether you’re preparing for a Phase I trial or scaling for global market entry, we keep your team compliant, efficient, and inspection-ready.

​​

Clinical Strategy & Regulatory Readiness

• FDA Pre-IDE/Pre-IND and regulatory meeting support

• Global study planning and development timelines

• Development of protocols, study plans, and essential documentation

• Regulatory pathways and risk mitigation guidance

​

Study Management & Oversight

• Site and CRO/vendor identification, qualification, and oversight

• Ethics submissions and IRB coordination

• Site initiation, training, and ongoing engagement

• Trial supply management and IP accountability

• Issue tracking and resolution coordination

​

Clinical Software Solutions & Technology Support

• Support selection and qualification of systems such as:

  • Electronic Data Capture (EDC)

  • eTMF (electronic Trial Master File)

  • CTMS (Clinical Trial Management System)

• Ensure system setup aligns with operational workflows and GCP compliance

• Coordinate training, testing, and system oversight in collaboration with vendors

​

Monitoring & Site Support

• Conduct GCP-compliant site monitoring (on-site and remote)

• Track Protocol Deviations and implement CAPAs

• Perform source document verification and resolve Case Report Form (CRF) queries

• Manage visit reports, follow-up letters, and inspection preparation

​

Close-Out & Final Reporting

• Trial close-out activities and reconciliation

• Final site documentation review and archival

• Coordination with data management and biostatistics for report completion

• Support final CSR development and submission readiness

​

Post Study Regulatory Support

• Operations and support on BIMO and Regulatory Review process

 

We streamline complex clinical development with expert, end-to-end operational and regulatory support—so you can stay focused on innovation while we ensure execution with quality, compliance, and efficiency.