Clinical & Medical Review / Monitoring Services

• Product Development planning
• Document design, review and sign off from a medical point of view (Investigator Brochure, Protocol, CRF, Informed Consent, Study Manual, Statistical Analyses Plan, Data validation Plan, Study Reports, SAE narratives)
• Study decisions regarding in/exclusion deviations, dosing questions, concomitant medication requests, emergencies (including 24/7 coverage)
• Listing review of study data (demographics, physical exams, vitals, dosing, labs, EKG, concomitant medications, adverse events, efficacy parameters, protocol deviations) and cross referencing critical data fields for consistency
• Coding review
• Trend analyses for safety parameters during the trial
• Data clarification
• SAE narrative writing and submissions to regulatory bodies
• SAE reconciliation and coding
• Literature evaluations (scientific, efficacy, safety and competitive analyses)
• Medical Monitoring Services
• Ongoing resolution of medical queries related to protocol-specific eligibility criteria, medical queries raised by the DCGI, IEC or DSMB and other protocol-related queries (e.g. dosing schedule, visit-procedures)
• Review of protocol violations, protocol deviations, re-entry criteria, study drug discontinuation criteria and measures to avoid future protocol violations including investigator site training
• Medical representation at Investigator Meetings (including protocol training for site teams and clarification of protocol related queries), DSMB Meetings, IND Committee Meetings and DCGI meetings
• Medical review of safety data on an ongoing basis (laboratory /other tests) and real-time tracking of efficacy end-points as applicable

Our medical monitoring capabilities include

• Medical monitoring and data surveillance plan
• Medical support for investigator sites and project teams
• 24/7 medical support
• Development and delivery of project-specific medical training
• Responding to subject eligibility and withdrawal questions
• Medical review of adverse events
• Review of relevant safety parameters and alert reports
• Medical review of coding
• Medical review of clinical study reports
• Literature review
• Medical oversight of the trial including medical issues arising from conduct

Pharmacovigilance / Safety

• Processing of Serious Adverse Events (SAEs), including expedited report generation and submission to regulatory authorities, ethic committees and investigator sites as applicable
• Development and implementation of a comprehensive and customized safety plan (DSAUR, PSUR, RMP)
• Review of medically coded data on adverse events and concomitant medications data
• Vigilant monitoring for Adverse Events (AEs) including review of AEs of clinical interest, clinically significant laboratory abnormalities and Adverse Events leading to permanent discontinuation of the study medication
• Investigator team training on safety reporting and clarification of safety related queries during Interim Monitoing Visits.
• Data Safety and Monitoring Board (DSMB): needs experienced physicians and statisticians to create excelent decisions for the patients, the investigators, the product and the sponsors.
• Maintaining updated safety database for clinical trials
• Support SAE reconciliation between clinical and safety database

Medical Writing

Our medical writers work with doctors, scientists, and other subject matter experts, creates documents that effectively and clearly describe research results, product use and other medical information. The medical writer also makes sure the documents (e.g. Clinical Trial Protocols, Case Report Forms, Clinical Trial Reports, Patient information leaflets, Patient information, Marketing Brochures) comply with regulatory, journal, or other guidelines in terms of content, format and structure.

Medical writing is a service providing special skill to produce well-structured documents that present information clearly and concisely. A growing number of new drugs go through the increasingly complex process of clinical trials and regulatory procedures that lead to market approval. This drives a demand for well written, standards-compliant documents that science professionals can read and understand easily and quickly.

Regulatory Medical Writing

means creating the documentation that regulatory agencies require in the approval process for   drugs, medical devices and biologics. Regulatory documents can be huge and are formulaic. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents (e.g. in Common Technical Documents [CTD] format) that summarize and discuss the data a company gathers in the course of developing a medical product.

Educational Medical Writing

means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals. These include sales literature for newly launched drugs, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists, and programs and enduring materials for continuing education (CE) or continuing medical education (CME).

         Medical Writing, Consultation and Training

• Study design and clinical study protocol development (phase I-IV)
• Development of clinical study reports per ICH-GCP (phase I-IV)
• Compilation of Investigator Brochure per ICH-GCP
• Medical review of clinical trial-related documents (incl.ICD, CRF, DVP, SAP, etc.)
• Protocol feasibility conduct, analysis and reporting
• Clinical development plans
• Therapeutic area training and guidance

GCP & Medical Writing Training

At LaNova Consulting, we believe in sharing our own experience with the next generation of clinical research professionals. Such a transfer of knowledge has proven fruitful, combining experience with new ideas and bringing together the latest developments from industry and academia.

By participation within the Medical Research Management – Diploma Program established in the Medical College at the AL IMAM University in Riyadh the related tasks and responsibilities according to ICH-GCP guideline and legal requirements will be discussed. The training program covers all topics of relevance for a high-quality conduct.

According to legal requirements meanwhile implemented by the Ethics Committees, physicians who want to participate in the conduct of clinical trials need proof of GCP training.

Upon request our experienced instructors also train you and your team on a spot at your investigational site or during investigator meetings.