Safety
LBR’s Safety Services ensure successful client outcomes and include:
- Creating SAE Narratives
- Creating MedWatch Forms
- Expedited Safety Reporting to the sponsor
- Submitting IND Safety Reports to IRBs on behalf of sites
- Notifying Investigators of IND Safety Reports
- Medical Monitoring
Medical Writing
Medical Writing requires a thorough knowledge of medical science, clinical research, and FDA guidance/regulations. The LBR medical writing team is highly qualified as demonstrated by their relevant industry experience, advanced degrees and/or professional credentials, and medical writing skills. In addition, our medical writers understand the nuances and terminology of many different therapeutic areas and possess excellent medical editing and publishing skills.
Examples of therapeutic indications:
- Therapeutic Areas of Pain (e.g., general and arthritis/osteoporosis)
- Rare/Orphan Indications
- Pediatrics
- HIV
- Vaccine
- Oncology (prostate, lymphoma, brain, ovarian and small cell lung)
- Contraceptive Agents (hormonal and barrier)
- Medical Device
- Veterinary Reproductive Agents
Medical Writing Services Include:
- Preclinical Study Reports
- Clinical Study Reports (Phases 2 through 4)
- Investigator's Brochure and Updates
- Informed Consent
- Regulatory Submissions
- Expert Reports
- Product Dossiers
- Safety Narratives
- Protocols
- Standard Operating Procedures
- Project plans
- Package Inserts
- Labeling
Training
Training Services are available for Sponsor companies of all sizes. LBR provides training modules for faculty and administrators that are designed to enhance personnel management, research, evaluation, reporting and process skills.
Training Services Include:
- Good Clinical Practices
- Good Manufacturing Practices
- Medical Writing
- IND Training
- Quality Assurance Auditing Training
- Project-Specific Training
