As a medical writer and medical science liaison (MSL), you understand the importance of clear and concise communication in the healthcare and pharmaceutical industries. At MIRI Clinical Research Consulting, we recognise the critical role that medical writers and MSLs play in ensuring the success of clinical research projects. Our team is committed to providing tailored project management services to support your clinical research endeavours.

1. Medical Writing Services

Protocol Development:

• Protocol Writing: Crafting comprehensive and precise clinical trial protocols, including objectives, design, methodology, statistical considerations, and operational aspects.
• Protocol Amendments: Updating and revising protocols based on regulatory feedback, interim results, or changes in study design.

Regulatory Documents:

• Investigator’s Brochures (IB): Creation and maintenance of IBs to provide investigators with comprehensive information about the investigational product.
• Clinical Study Reports (CSR): Writing detailed CSRs summarizing study methodology, data analysis, and outcomes as per ICH guidelines.
• Informed Consent Forms (ICF): Drafting clear and ethical ICFs to ensure participants are fully informed about the study.

Scientific Publications:

• Manuscripts for Peer-Reviewed Journals: Writing and submitting research articles, reviews, and case studies to scientific journals.
• Abstracts and Posters: Preparing abstracts and posters for presentation at scientific conferences and symposia.
• Review Articles: Composing comprehensive review articles summarizing current knowledge on specific topics.

Regulatory Submissions:

• Submission Dossiers: Preparing documentation for regulatory submissions, including New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs).
• Response to Regulatory Queries: Writing responses to questions from regulatory authorities to support the approval process.

Patient and Investigator Communication:

• Patient Narratives: Writing detailed patient narratives for inclusion in clinical trial documentation.
• Investigator Newsletters: Crafting newsletters to keep investigators informed about study progress, updates, and other relevant information.

Standard Operating Procedures (SOPs):

• Development of SOPs: Writing and updating SOPs to ensure compliance with Good Clinical Practice (GCP) and regulatory requirements.
• Training Materials: Creating training manuals and materials for clinical trial staff and investigators.

2. Medical Science Liaison (MSL) Services

Scientific Expertise and Support:

• KOL Engagement: Identifying, developing, and maintaining relationships with Key Opinion Leaders (KOLs) and healthcare professionals.
• Advisory Boards: Organizing and facilitating advisory board meetings to gather insights and feedback from experts in the field.

Clinical Trial Support:

• Site Selection and Support: Assisting in the selection of clinical trial sites and providing scientific support to investigators.
• Study Coordination: Coordinating with clinical trial sites to ensure adherence to protocols and regulatory requirements.

Data Communication:

• Scientific Presentations: Delivering presentations at scientific conferences, investigator meetings, and other events to communicate clinical trial results and other scientific data.
• Publication Planning: Developing publication strategies and managing the dissemination of clinical trial results through scientific publications and presentations.

Regulatory and Compliance Support:

• Regulatory Liaison: Acting as a liaison between the company and regulatory authorities, ensuring compliance with all regulatory requirements.
• Compliance Training: Providing training to internal teams and external partners on regulatory and compliance issues.

Medical Information:

• Response to Inquiries: Responding to medical and scientific inquiries from healthcare professionals, patients, and other stakeholders.
• Medical Education: Developing and delivering educational programs and materials for healthcare professionals to enhance understanding of the investigational product.

Market Insights:

• Competitive Intelligence: Gathering and analyzing information on competitors’ products and strategies to inform clinical and commercial strategies.
• Scientific Landscape Analysis: Conducting thorough reviews of the scientific literature and clinical trial databases to provide insights into the current research landscape.