FAQs

General Questions

  • Peer AI is an AI-powered platform delivering the easiest path to automation for regulatory medical writing to pharmaceutical, biotechnology, CROs, and medical device companies.

  • Yes, we are live with customers and generating regulatory documents, including Clinical Study Reports (CSRs), Safety Narratives, and Module 3. Contact us to discuss your needs and we will quickly set your up with Peer’s technology solution.

  • Yes. Peer has built a generic document generator and can support an array of regulatory documents. We can add new documents quickly if there is interest. Reach out with your specific need to hello@getpeer.ai.

Regulatory Medical Writing Solutions

  • Our AI platform creates high-quality:

    • Clinical Study Reports (CSRs)

    • Safety Narratives

    • Module 3 documents

    • Investigator Brochures

    • Clinical Trial Protocols

    • Informed Consent Forms

    Contact us for our expanding product portfolio of regulatory documents

  • We stay up-to-date with FDA, EMA, and ICH guidelines, ensuring compliance for:

    • Pharmaceutical companies

    • Biotechnology companies

    • Medical device manufacturers

    • Contract Research Organizations (CROs)

  • Peer AI reduces generation time by up to 90%, improves quality, and minimizes change management impact. You can read more about our impact in a recent case study.

Expertise and Support

  • Our team includes experienced medical writers and engineers with expertise in:

    • Regulatory affairs

    • Clinical research

    • Life sciences

    • Clinical development

    • Technology platform development for Life Sciences

    • Generative AI

    • Life Sciences software development

  • Contact us to discuss project needs and schedule a demo.

  • Peer is a cloud-based SaaS solution deployed and operated in our AWS environment. Alternate deployment options may be available on a per customer basis.

  • We provide:

    • Email support

    • Phone support

    • Training sessions

    • Webinars

Technology and Data

  • We leverage GenAI for end-to-end regulatory writing, ensuring:

    • Accuracy

    • Consistency

    • Efficiency

  • AI reduces submission time, processes large datasets efficiently, and applies rigorous QC criteria.

  • We ingest:

    • Structured data

    • Unstructured data

    • Human-readable PDFs

    • DocX files

    • RTF files

    • CSV formats

  • Yes, Peer support configuration for customer needs, including templates, style guides, tone, etc.

Integration and Compatibility

  • Yes, our inbound APIs are compatible with:

    • Medidata EDC

    • Veeva Vault

    • Others

  • Yes, we export docX drafts for seamless integration.

Data Security and Compliance

  • We use:

    • Secure servers

    • Encryption

    • Access controls

    • GDPR compliance measures

  • We adhere to GDPR regulations and implement data protection measures.

Regulatory Compliance

  • Automated writing reduces errors, increases efficiency, and ensures FDA, EMA, and ICH compliance.

  • Peer has implemented a strict data segregation architecture where data related to a project is managed in a project specific schema. Data is prevented from  moving between projects and kept secure using our defense in depth approach to layered security and risk mitigation

Regulatory Medical Writing Best Practices

  • Writing high-quality Clinical Study Reports (CSRs) requires attention to detail, clarity, and compliance with regulatory guidelines. 

    Best practices include:

    • Clear and concise writing: Avoid ambiguity and ensure easy understanding of complex data.

    • Accurate and comprehensive data reporting: Present all relevant data, including adverse events, in a transparent and unbiased manner.

    • ICH E3 compliance: Adhere to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E3 guidelines for CSR structure, content, and quality.

    • Consistent formatting: Use standardized templates and formatting to facilitate navigation and review.

    • Data integrity: Ensure data accuracy, completeness, and consistency throughout the report.

    • Contextualization: Provide context for study results, including discussions of limitations and implications.

    • Regulatory compliance: Familiarize yourself with relevant regulations, such as FDA, EMA, and ICH guidelines

  • AI technology significantly enhances regulatory medical writing quality by:

    • Automated quality control (QC) checks: AI-powered tools detect and correct errors, ensuring consistency and accuracy throughout the document.

    • Consistent formatting: AI applies standardized formatting and styling, facilitating navigation and review.

    • Real-time grammar and syntax analysis: AI-powered grammar checks ensure error-free writing, improving overall readability.

    • Reduced human error: AI minimizes the risk of human error, ensuring accuracy and reliability in data reporting and analysis.

    • Improved data integrity: AI validates data accuracy, completeness, and consistency, ensuring reliable results.

    • Enhanced clarity and concision: AI-assisted writing tools suggest improvements for clearer, more concise language.

    • Regulatory compliance checks: AI verifies adherence to relevant regulations, guidelines, and industry standards.

    • Automated hyperlinking, citation and referencing: AI manages citations and references, inserts hyperlinks efficiently, ensuring accuracy and consistency.

    Additional benefits:

    • Increased efficiency: AI streamlines the writing process, reducing time spent on QC checks and formatting.

    • Scalability: AI handles large volumes of data and documents, making it ideal for complex regulatory submissions.

  • Peer AI provides automated solutions for:

    • Clinical Study Reports (CSRs)

    • Safety Narratives

    • Module 3 documents

    • Investigator Brochures

    • Clinical Trial Protocols

    • Informed Consent Forms

    Contact use for our expanding product portfolio of regulatory documents

  • Peer AI provides custom automated solutions for medical device companies. Contact us for more information.

Industry-Specific Solutions