DATA MANAGEMENT

Medical & Scientific Writing Service

TAAB medical writers:

• Autonomously drive the document development process

• Make early contact with the team, identify key stakeholders, and establish clear expectations

• Work with the team to develop timelines, determine project drivers, and assess all potential risks early in the process

• Lead document development, develop and refine key messages, and coordinate and manage input from cross-functional stakeholders

• Manage client review cycles, comment adjudication, and quality review

• Facilitate signoff, publishing, and distribution of final, approved documents

Our medical writing portfolio encompasses execution of hundreds of deliverables spanning all types of clinical, safety, and other scientific communication documents, including but not limited to:

Clinical

• Clinical Study Reports (CSRs)

• Protocols and Protocol Amendments

• Investigator’s Brochures (IBs) and IB Updates

• Regulatory Submission Summary Documents (IND/NDA/MAA/CTA)

• Responses to Questions (RTQs)/Regulatory Responses (across multiple health authorities)

• Pre-Meeting Packages/Briefing Packages

• Orphan Drug Applications

• Pediatric Investigation Plans

• Pediatric Study Plans (including waivers)

• Health Outcomes Economics/Real World Evidence Documents

• Fast Track Designation

• Orphan Drug Designation (ODD) Application/Annual Reports

• Immunogenicity Reports

• Ethnic Sensitivity Reports

• Conditional Marketing Authorization (CMA)

Safety

• Development Safety Update Reports (DSURs)

• Periodic Benefit Risk and Evaluation Reports (PBRERs)

• Periodic Safety Update Reports (PSURs)

• Periodic Adverse Drug Experience Reports (PADERs)

• Risk Management Plans

• Assessment of Benefit Risk (ABR)

• Annual Reports

• Patient Safety Narratives

• Pharmacology, Pharmacokinetic, and Toxicology Reports (in vivo/in vitro)

• Bioanalytical Reports

Nonclinical

Diagnostics

• Protocol Proposals

• Clinical Validation Plan/Clinical Performance Plan

• Clinical Validation Report/Clinical Performance Report

• Clinical Study Protocols (CSPs)

• Clinical Study Reports (CSRs)

• Intended Use Statements

• Performance Evaluation Plan (PEP)

• Performance Evaluation Report (PER)

• State-of-the-Art Determination (SOTA)

• Scientific Validity Report (SVR)

• Medical Assessment

• Medical Opinion Documents

Devices

• Clinical Evaluation Plans (CEPs)

• Clinical Evaluation Reports (CERs)

• Investigational Device Exemption (IDE)

Publications

• Scientific Manuscripts/Abstracts

• Posters

• Literature Reviews/Summaries

• Oral Presentations

Other Scientific Documents

• Plain Language Documents (protocol synopses, results summaries)

• Informed Consent Forms (ICFs)

• Regulatory White Papers

• Consumer Health Product Documents