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Medical Writing

At VAICS, Medical Writing is a consequential service integral to the advancement of clinical research and regulatory success. Our team of seasoned medical writers is adept at transforming complex scientific data into clear, precise, and impactful documents that meet stringent regulatory standards and communicate effectively to diverse stakeholders. We partner closely with our clients to deliver high-quality, scientifically rigorous documents that play a critical role in clinical trials, regulatory submissions, and post-marketing activities.

Our key services

Take a quick look at all medical writing services that VAICS can help you with.

Clinical study protocol development

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Clinical study reports (CSRs)

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Investigator’s brochures (IBs)

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Manuscript writing and publication support

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Regulatory submission documents

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Clinical summaries and overviews

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Post-marketing surveillance documents

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Clinical study protocol development

Comprehensive protocol design

VAICS offers end-to-end protocol development services, ensuring that every aspect of your clinical trial is meticulously planned and documented. Our protocols are designed to meet the highest scientific standards, incorporating the latest methodologies and statistical techniques.

Regulatory alignment

We ensure that your protocols are fully compliant with ICH-GCP guidelines and tailored to the specific requirements of global regulatory authorities, such as the FDA and EMA. Our team also integrates risk management strategies to address potential challenges during the trial.

Collaborative development

Our experts work closely with your clinical and regulatory teams to ensure that the protocol is aligned with your trial objectives and supports the successful execution of the study.

Clinical Study Reports (CSRs)

Data synthesis and analysis

Our Medical Writing team excels in interpreting and synthesizing clinical trial data into coherent narratives that accurately reflect the study’s outcomes. We ensure that CSRs are comprehensive and aligned with regulatory expectations.

Regulatory submission ready

Every CSR we produce adheres to ICH E3 guidelines, ensuring that it meets the exacting standards required for regulatory review. We focus on clarity, accuracy, and completeness, making sure that the document effectively supports your submission.

Holistic documentation

Our CSRs include detailed descriptions of study design, methodology, statistical analysis, and results, providing a full and transparent account of your trial’s findings.

Investigator’s Brochures (IBs)

Comprehensive data presentation

VAICS develops IBs that provide a comprehensive overview of the investigational product, including preclinical and clinical data, ensuring investigators have the necessary information for safe and effective trials.

Ongoing updates

We provide regular updates to the IB as new data emerges, ensuring that investigators always have the most current information regarding the investigational product.

Regulatory compliance

Our IBs are developed in accordance with international regulatory standards, ensuring that they meet the requirements of agencies such as the FDA and EMA.

Manuscript writing and publication support

Strategic journal selection

We assist in selecting the most appropriate journals for your research, maximizing the visibility and impact of your study.

Expert manuscript development

VAICS transforms clinical trial data into high-quality manuscripts suitable for submission to peer-reviewed journals. We ensure that manuscripts are well-structured, scientifically sound, and aligned with the guidelines of target journals.

Comprehensive publication support

From manuscript development to submission and peer-review support, we provide end-to-end assistance to ensure successful publication.

Regulatory submission documents

CTD module development

Our team is proficient in creating and compiling the clinical, nonclinical, and quality sections of the Common Technical Document (CTD), ensuring they are ready for eCTD submission.

Comprehensive risk management plans (RMPs)

We develop RMPs that thoroughly assess and manage the risks associated with your investigational product, meeting the stringent requirements of regulatory bodies.

Strategic briefing documents

VAICS prepares briefing documents that effectively summarize key findings and justifications for regulatory meetings, ensuring that your position is clearly communicated and supported by data.

Clinical summaries and overviews

In-depth clinical overviews

Our team develops comprehensive clinical overviews that provide a detailed synthesis of clinical data, presenting a clear narrative on the product’s safety, efficacy, and overall benefit-risk profile.

Concise clinical summaries

We create summaries that are not only regulatory-compliant but also designed to facilitate efficient review by regulatory authorities, ensuring that your submission process is as smooth as possible.

Post-marketing surveillance documents

Detailed periodic safety update reports

VAICS develops PSURs that provide a thorough analysis of the product’s safety profile over specified periods, ensuring ongoing compliance with regulatory requirements.

Continuous risk-benefit evaluations

Our ongoing assessments of the product’s risk-benefit ratio help you maintain up-to-date product labeling and usage guidelines, ensuring patient safety and regulatory adherence.

Why choose VAICS for Medical Writing?

VAICS is committed to excellence in Medical Writing. Our team’s deep expertise in clinical research, regulatory affairs, and scientific communication ensures that all documents are scientifically rigorous but also clear, concise, and impactful. We pride ourselves on our ability to deliver documents that meet the highest standards of quality, supporting successful clinical trials and regulatory submissions. Whether you’re navigating the complexities of protocol development, preparing for regulatory submissions, or communicating your findings to the scientific community, VAICS can be your trusted partner in medical writing.

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