Our Expertise

Medical writers are critical to the communication process of outlining the goals, strategies, analysis, and medical understanding of a clinical trial/program to patients, sites, sponsors, and regulatory agencies. Our successful clients cite these reasons for choosing to work with us.

  • We offer medical writing services in a wide range of therapeutics areas performed by experienced medical writers with PhD level degrees in life science and over 10 years of experience. These include study-specific documents and development-program documents.
  • The medical writing service is fully integrated into multi-disciplinary clinical development teams, specifically safety, biostatistics and data management aimed at producing the highest-quality, most regulation-compliant, clear, and informative documents while adhering to timelines.
  • Our scientific-minded writing team has significant experience preparing clinical documents including protocols, clinical study reports (CSRs), and Investigator’s Brochures.
  • We excel in developing regulatory documents to support drug, biologic, device, and diagnostic marketing submissions to regulatory agencies worldwide.
  • We understand the complexities of writing in a highly regulated environment and the challenges of varied requirements of different regulatory agencies.

Medical Writing for Clinical Trials & Regulatory Submissions

We provide medical writing support for the full life-cycle of a product’s development, beginning with early-stage development through marketing application and post-approval. We offer rapid turnaround to meet tight timelines, and flexible, efficient processes for any project large or small. Using in-house or sponsor-supplied document templates, we apply best practices for content, format, and style to meet global technical and regulatory requirements. Our expert medical writing team supports the development of the following types of documentation:

Clinical Trial & Program Documentation

  • Protocol Synopsis, Protocols, and Amendments
  • Informed Consent Forms
  • Clinical Study Reports (CSRs)
  • Safety Narratives
  • Clinical Development Plans
  • Investigator Brochure and Patient Information Leaflets
  • Annual reports
    • Periodic safety update reports (PSURs)
    • Development safety update reports (DSURs)
    • Periodic benefit-risk evaluation reports (PBRERs)

Regulatory Submission Documents

  • Marketing Applications in eCTD format (including IND, CTA, NDA/sNDA, MAA, NDS, jNDA)
  • Clinical & Non-Clinical Summaries (Module 2)
  • Integrated Summaries of Efficacy and Safety (Module 5)
  • Responses to Agency reviewers
  • Regulatory Briefing documents for Agency meetings, including:
    • Pre-IND, End of Phase 1,  End of Phase 2/3, Pre-NDA  and  Advisory Committee
  • Orphan Drug Designation Applications
  • Risk Management Plans

eCTD services

  • Create and edit eCTD documents according to ICH and national regulatory authority guidelines.
  • Manage documents and eCTD sequence lifecycles on a  dedicated Document Management System in accordance with regulatory requirements.
  • Create and publish eCTD sequences on a dedicated eCTD compilation system in accordance with regulatory requirements.
  • Validate eCTD sequences using specialized validation tools in accordance with ICH and national regulatory authority validation criteria.
  • Submit eCTD sequences to regulatory agencies.

Examples of Our Work

Relative Risk of Lung Cancer 

January 15th, 2021|2 Comments

We compared the difference in relative risk (RR) of lung cancer between the intervention and control groups. The hypothesis was as follows: H1: The intervention group will have an increase in relative risk (RR) of [...]

Blood Pressure

January 14th, 2021|0 Comments

We examined the difference in blood pressure between patients with cancer and patients without cancer. The hypothesis was as follows: H1. There is a significant difference in blood pressure between patients with cancer and [...]

Bending Stiffness

January 13th, 2021|0 Comments

We measured the difference among the 2.0mm RP and 2.0mm SP in bending stiffness, bending strength, and bending structural stiffness. The hypothesis was as follows: H1: There is a significant difference among the 2.0mm RP [...]

Compound D-600

January 13th, 2021|0 Comments

We examined the effect of compound D-600 (methoxyverapamil) on gluconeogenesis. The hypothesis was as follows: H1: There is a significant effect of compound D-600 on gluconeogenesis. A regression analysis was conducted. There was a [...]

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