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Medical Writing

Leading Drug Development with Excellence in Medical Writing Services

At Biotrial, we understand that the drug development process is a meticulous journey from conception to approval. Our expert medical writing services provide support, ensuring that critical regulatory documents reflect the expert-quality data and rigorous analyses that characterize your product’s journey.

Our experienced medical writers craft content with an intimate understanding of pharmaceutical studies and technical requirements. With a profound knowledge base and commitment to Good Clinical Practice (GCP) guidelines, our work is synonymous with precision and compliance.

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Services

Our Medical Writing team assists sponsors in writing and preparing all necessary documents for clinical trials, preclinical projects, and regulatory submissions while ensuring all clinical trial deliverables are eCTD compliant.

  • Clinical Study Protocol / Investigation Plan
  • Clinical Study Report / Investigation Report
  • Development Safety Update Report (DSUR), periodic safety update report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER)
  • Lay summaries
  • Medical narrative
  • Clinical Study Report (CSR) anonymization
  • Investigator Brochures
  • CT.gov and CTIS study registration and reporting
  • Scientific publications
  • QC of trial documents
  • Preclinical trial plans and reports

Added Values

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Strategic Medical Writing Expertise: Accelerating Your Drug to Market

Navigating the complex world of clinical trials and drug submissions necessitates a strategic approach underpinned by extensive experience. Biotrial’s medical writers bring their technical expertise and regulatory affairs knowledge to each project, ensuring that every document—from study protocols to submission packages—meets the exacting standards of regulatory bodies.

Whether your trial is at the stage of initial application, interim study reports, or final submission, our content is meticulously designed to meet and exceed the nuanced requirements of the submission process.

Robust Medical Writing Services Supporting Pharmaceutical Companies

Our commitment to service excellence makes us a preferred CRO for pharmaceutical companies looking to streamline their clinical trial and submission process. Biotrial provides dedicated support, utilizing our writers’ expertise to create technical documents that align with the therapeutic narrative of the product.

Unique Experience in Diverse Therapeutic Areas

Our medical writers possess a collective experience that spans various therapeutic areas, enabling us to support a range of clinical studies with tailored content. This diversity of experience ensures that our clients receive expert services tailored to their specific project needs.

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Expertise That Complements Your Clinical Trial Team

Biotrial’s medical writers are an extension of your team, offering the support and knowledge required to propel your drug development forward. We work closely with clinical experts and regulatory professionals to ensure that every trial document and report is a testament to the quality and safety of your patient care commitment.

Tailored Support for Companies at Every Step

From emerging biotech firms to established pharmaceutical companies, Biotrial offers a breadth of medical writing services to support the drug development lifecycle. We recognize that time is critical, and our process is streamlined to save you time while maintaining the integrity of your data and product story.

Seamless Pharmaceutical Publishing and Submission

Our approach to medical writing extends to the careful planning and execution of pharmaceutical publishing. Every content piece provided for your study aims to communicate complex information clearly and concisely, ensuring that submission to regulatory sites is seamless and efficient.

A Trusted Partner in Your Drug Development Journey

As a leading CRO, Biotrial’s commitment is to stand beside you as a trusted partner. We pride ourselves on the quality of our work and the positive client experiences we facilitate. When you choose Biotrial’s medical writing service, you choose a team that’s dedicated to adding value at every opportunity throughout the drug development cycle.

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