The global regulatory requirements, such as the EMA in Europe and the FDA in the United States often make it complex and demanding to create healthcare documents that are consistent and compliant worldwide. In addition, hiring the right talent with the ability to understand and interpret statistical clinical analyses and scientific study designs to convey the right implications of your research findings further complicates the process of medical writing.
Balance the scientific accuracy of your content with the perfect blend of intricate research details, drug mechanisms, and medical practices without oversimplifying or introducing errors with our professional medical writing services. Our 19+ years of experience in serving pharmaceutical companies, Clinical Research Organizations (CROs), healthcare providers, regulatory agencies, and academia enables us to develop accurate and compliant medical manuscripts, scientific narrations, and regulatory submissions. We follow established quality assurance practices including data verification and peer review to ensure accuracy and prevent non-compliance.
Leverage our expert medical writing services to delegate your biomedical documentation requirements and shift your focus to research and development.
Customized Medical Writing Solutions We Offer
We have developed a medical writing consultant platform to help you find the right talent for disseminating your findings, breakthroughs, and communications. Explore some of the key offerings in our portfolio.
Regulatory Medical Writing Services
Create regulatory documents that comply with global standards using eCTD software and Common Technical Document (CTD) for seamless submissions. We help you prepare comprehensive dossiers to expedite approvals.
Clinical Study Reports (CSRs)
Compile and present clinical reports and trial data as per the ICH E3 guidelines using reporting tools and data analytics. We merge clinical findings and statistical results to create narratives for regulatory submissions.
Pharmacovigilance Safety Reports
Generate drug safety reports, like Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs) using signal detection tools and pharmacovigilance databases to analyze and document safety data.
Patient Safety Narratives
Collate patient profiles using clinical databases and data extraction tools to identify key safety events. Our clear and concise narratives process complex clinical data efficiently to enhance your pharmacovigilance efforts.
Informed Consent Documents
We develop compliant and ethically sound Informed Consent Forms (ICFs) and Informed Consent Documents (ICDs) using readability tools. This enables the trial participants to comprehend the scope of involvement.
Investigator Brochures (IBs)
Receive comprehensive Investigator Brochures (IBs) from our professionals who integrate clinical and preclinical data using document management systems for seamless version control and compilation.
Disclosure Documents
We develop disclosure documents that are compliant with global clinical trial registries using data disclosure tools. Our documents meet the regulatory database requirements and report your trial information accurately.
Scientific Communications and Journals
We use data visualization and reference management tools to create conference abstracts and journals. Our resources collaborate with your team to translate scientific data into narratives for academic audiences.
Manuscript Preparation
We use citation management tools and editing platforms to develop submission-ready manuscripts. Our experts integrate literature reviews and data analysis with journal-specific guidelines to support your publication goals.
Our Approach to Medical Writing
We follow a meticulously structured process that combines advanced technology with industry expertise to ensure precision and compliance.
Understanding Medical Writing Requirements
Gathering and Analyzing Literature
Drafting Structured Documents
Statistical Validations and Peer Reviews
Feedback and Refinement
Iterative Revisions and Finalization
Our Technical Capabilities
Sectors We Cater to
Pharmaceutical Companies
Biotechnology Firms
Healthcare Providers
Medical Device Manufacturers
Research Institutions
Healthcare Marketing Agencies
Academic Institutions
Medical Publications
Government Agencies
Why Should You Choose Our Medical Writing Company?
We combine scientific expertise with clear communication to deliver content that advances your objectives and meets industry standards. Here are some of our defining strengths.
Confidentiality Protocols and HIPAA Compliance
We prioritize data protection with HIPAA-aligned measures to safeguard your client and patient confidentiality. Our practices, such as controlled access, secure data storage, and encryption, help mitigate risks and improve compliance.
Medical Writing Excellence
Our extensive experience of working with a diverse medical writing clientele has fortified our expertise and dependability while instilling confidence in our clients. We consistently deliver professional, results-oriented content that meets industry standards.
Robust Quality Assurance (QA)
We follow meticulous QA practices and comprehensive reviews to ensure scientific accuracy, clarity, and consistency in your medical documents. This approach eliminates errors and increases the credibility of your submissions.
Advanced Platforms for Medical E-Docs
We deliver medical documents efficiently using advanced tools and medical writing consultant platforms that facilitate collaboration, integration, and seamless access within your systems. This enhances the dissemination and usability of clinical and scientific content.
Customized Narratives and Medical Writing Assistance
All our writing services for healthcare, pharmaceutical, and clinical purposes are customized to your project objectives, target audiences, and timelines. This approach boosts the overall impact of your medical communications.
Proficiency Across Multiple Health Disciplines
All our professionals have extensive knowledge of various healthcare and pharmaceutical processes, which enables us to create accurate documents that are tailored to your specific area of focus. This approach ensures precision and relevance.
Additional Services You Can Benefit From
Discover molecular insights using reports from NMR spectroscopy and X-ray crystallography to interpret biomolecular interactions to facilitate drug discovery.
Integrate pharmacokinetics, high-throughput screening, and ADME studies to streamline commercialization and improve drug efficacy.
Harness big data analytics, machine learning algorithms, and bioinformatics to extract crucial insights from research reports and drive informed decision-making.
Refer to biological databases and leverage advanced computational tools to optimize your data analysis and support your genomics and proteomics research.
Outsource Medical Writing Services to Flatworld Solutions
Our medical writing outsourcing solutions meet the high standards set by the pharmaceutical, healthcare, and biotechnology sectors. We develop detailed regulatory submissions, including investigator brochures, new drug applications, and clinical study reports, ensuring precision and compliance at every step.
Every document we develop adheres to FDA, EMA, and other global guidelines. Our deep understanding of therapeutic areas and advanced data interpretation techniques help us transform complex scientific data into clear narratives that enhance stakeholder communication and facilitate swift regulatory approvals.
Besides, all our solutions are scalable and seamlessly adapt to your evolving needs. This provides you with the agility required to accelerate your documentation's time to market and incorporate the latest developments into every paper you publish.
Engage our medical writing consulting services to improve your clinical documentation and effectively disseminate your research findings.
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Case Studies
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Flatworld Helped a US-based Healthcare Client Develop a Forecasting Model
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Flatworld Provides Online and Offline Research Support to Evaluate Competition
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FWS Provided Key Opinion Leaders (KOL) Profiling to a Top UK-based Med Firm
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FWS Provided a Detailed Porter Analysis and Web Research to a Leading US Technology Consulting Company
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Flatworld Solutions Provided Research Services to Top Hospitality Consulting Solutions Provider
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