Lonacas Consultants 

Our medical services include:

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• Proactively plan and coordinate to ensure departmental obligations are met.

• Develop clinical protocols for clinical studies of any complexity.

• Review and provide feedback on client-provided protocols, as required.

• Coordinate and complete risk assessment and management plans (RAMPs) for assigned studies.

• Review case report forms (CRFs) and statistical analysis plans (SAPs), as required, to ensure completeness and accuracy of clinical data collection and presentation for final analyses.

• Create clinical study reports (CSRs), standalone safety narratives, and integrated safety summaries for studies of any complexity and incorporate results and feedback from other departments assuring compliance with regulations, standard operating procedures (SOPs), Good Clinical Practice (GCP), and client expectations.

• Analyze and interpret clinical and safety results for studies of any complexity including vital signs, clinical laboratory values, adverse events (AEs), electrocardiograms (ECGs), diagnostic procedures, etc.

• Confirm accurate classification of events and medications using standardized coding systems.

• Prepare and review CSR appendices in accordance with project/client specifications and International Conference on Harmonisation (ICH) E3 guidance.

• Review and provide assistance in answering deficiency letters from regulatory agencies, as required.

• Perform literature searches/reviews as necessary to obtain background information for development of documents.

• Coordinate internal review and manage incorporation of external feedback for protocol and CSR documents assuring feedback is appropriately addressed.

• Perform quality control (QC) and editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.

• Actively participate in internal and external project team meetings, as required.

• Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines.

• Conduct all work in compliance with standard operating SOPs, GCP, and all regulatory guidelines.

• Maintain familiarity with client expectations and produce documents consistent with these.

• Monitor project performance to identify issues and report metrics.

• Other duties as assigned.