Medical Writing

Our medical writing capabilities

We understand that accurate and effective medical writing is critical to the regulatory success of a product and for optimal interactions with regulatory agencies. Our network consultants are seasoned professionals at the top of the medial writing field with a proven track record of developing a wide range of regulatory documents, across many therapeutic areas.

Early Engagement: We initiate early contact with your team, identifying key stakeholders and establishing clear expectations for the project.

Strategic Planning: We collaborate to develop realistic timelines, define project drivers, and proactively assess potential risks to ensure smooth progress.

Expert Leadership: We lead the document development process, crafting and refining key messages while coordinating input from cross-functional stakeholders.

Efficient Review Management: We manage client review cycles, expertly adjudicate comments, and conduct rigorous quality control reviews to ensure accuracy and clarity.

Seamless Finalization: We facilitate the sign-off process, ensuring timely publishing and distribution of approved documents.

Comprehensive medical writing

Our medical writers can translate complex scientific data into clear, concise, and credible documents that meet the highest regulatory and scientific standards.

Our services include:

• Pre-IND documentation
• Clinical trial protocols and reports
• Informed consents and assets
• Investigator brochures
• Regulatory submission documents (INDs, NDAs, BLAs, IMPDs)
• Safety and pharmacovigilance documents
• Scientific publications and presentations
  
  

Efficient document management

We can streamline the document lifecycle with comprehensive solutions for:

• Document authoring, review, and approval
• Version control and tracking
• Quality control and compliance
  
  

EMA Policy 0070 support for marketing applications and EU CTR for clinical trial submissions

EMA Policy 0070, officially known as the "European Medicines Agency policy on publication of clinical data for medicinal products for human use," mandates the proactive publication of clinical data submitted for new medicine approvals in the European Union (EU). This policy aims to increase transparency and public access to information about the efficacy and safety of medicines.

Key Impacts of EMA Policy 0070:

• Increased Transparency: By making clinical trials reports (CTRs) - previously better known as clinical study reports or CSRs - publicly available, it strives to foster greater transparency in the regulatory process. This allows researchers, healthcare professionals, and the public to scrutinize the data behind regulatory decisions.
• Enhanced Public Trust: Open access to clinical data can build public trust in the medicines approval process and in the safety and efficacy of authorized products.
• Furthering Research and Development: The availability of CSRs can facilitate further research and development of new medicines and treatments.
• Data Anonymization: The policy requires robust anonymization of clinical data to protect patient privacy, which adds complexity to the submission process.
  
  

Meeting the requirements of EMA Policy 0070 can be complex and time-consuming. Our network consultants can help you navigate this process with comprehensive support for:

• Redaction of Clinical Trials Reports (CTRs): We ensure your CTRs are meticulously anonymized to protect patient privacy while preserving the integrity of the scientific data.
• Development of Lay Summaries: We create clear and concise lay summaries that explain the clinical trial results in plain language for the general public.
• Submission Process Guidance: We provide expert guidance on the EMA's submission requirements and ensure your documents are compliant with Policy 0070.

Recent Projects:

• Medical support for international oncology submissions: One of Alacrita’s European medical team has supported a client with the registration of an oncology product for the treatment of renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC) in numerous territories outside the core USA and EU markets including China, Canada, Israel, Algeria, Turkey, Saudi Arabia, Lebanon, Australia, Hong Kong, South Korea, Singapore, Taiwan and Brazil.
  
  Core activities during this expert placement included writing documents for briefing documents and regulatory submissions (e.g. CSR, the summary of efficacy, the summary of safety and the overview), responding to questions from regulatory agencies, drafting the pediatric development plan and liaising with the team preparing the heath technology assessment for reimbursement.
  
  
• Interim medical support for clinical development: A major European pharmaceutical company required interim medical support for clinical development activities over a three-year period. Alacrita was engaged to provide the expertise.
  
  Acting as clinical directors, Alacrita’s consultants undertook the following activities:
  • Provision of strategic development advice in first-line pancreatic cancer, small cell lung cancer and other indications.
  • Protocol review and development in oncology indications.
  • Data review: data coding review and patient profile review.
  • Trial oversight.
  • Clinical study report writing oversight and manuscript creation.
    
    
• CMO support for biotech developing a new class of oligonucleotide therapy: Our client was developing a new class of oligonucleotide therapy, analogous to siRNA but with a very different activity/mechanism of action. The company was embarking on a rare disease project with exceptionally complicated pharmacology. Pharmacokinetics and pharmacodynamic studies are complicated by the nature of the target cells and the difficulty associated with the standard biomarkers which show a high degree of fluctuation even under normal conditions. As a result, the company faced a challenge in defining the RP2D during Phase 1 clinical studies and needed to build a strategy and set of assays to address these issues.
  
  One of Alacrita's clinical development specialists with clinical pharmacology expertise supported the client through trial design and regulatory submissions. He was supported by a medical writer and a biomarker specialist with deep experience in qualification of biomarkers as end points in clinical trials. Our consultants provided support over a two year period and the clinical trial was approved and initiated during that time.