Scientific Communications and Medical Review

Experienced Writers and Reviewers

Our writers have expertise in the following areas. Tap the blue boxes to learn more.

  • Scientific Content Responses

    • Standard responses
    • Interactive standard responses
    • Customized standard responses
  • Interactive Standard Content Responses

    • Easy to navigate and read
    • Autonomous and quick data analysis
    • Visually appealing
    • Higher customer engagement
  • Promotional and Medical Material Review

    • Reference review and formatting
    • Quality assurance/fact check
    • Dedicated medical reviewer
  • Slide Deck Development and Review

    • Presentation creation and review
    • Material development and writing
    • Design assistance
  • Publications Writing

    • Primary and secondary research manuscripts
    • Congress abstracts, posters, and slide decks for oral presentations
    • Newsletters, sponsored journals, and congress reports
    • Narrative reviews
    • Systematic reviews and meta-analyses
    • Journal supplements
  • Dossiers

    • AMCP Formulary Post-approval Dossiers
    • AMCP Pre-approval Dossiers
    • Global Value Dossiers
    • Clinical and Economic Evidence-Based Data for Value Message
    • Facilitate Reimbursement and Formulary Addition Considerations
  • FAQ Development

    • Brief document for verbal responses
    • Narrow and succinct
    • Scientifically accurate and balanced
    • Self-service medical information interfaces (e.g., portals, chatbots)
  • Infographic Creation

    • Easy to read and digest
    • Visually appealing
    • Upgraded and enriched experience
    • Converts complex data into a concise and highly visual document
    • Time-efficient tool for Medical Affairs Personnel during face-to-face interactions with HCPs
    • Effective and engaging leave-behind after HCP interactions
  • SOP Content Development

    • Ensure compliance with step-by-step instructions
    • Standardize routine tasks and complex processes
    • Enhance quality through transparency, consistency, and efficiency
    • Minimize miscommunication, errors, and reparations
  • Formulary Kits

    • Specific to a product
    • Safety, efficacy, and cost-effectiveness information
    • Additional prescribing guidelines for appropriate use to improve patient outcomes
    • Procedures for distribution, dispensing, and administering, as well as wholesale acquisition costs
  • Clinical Executive Summary Development and Maintenance

    • Concise and brief document specific to a product
    • Efficacy, safety, and health economics and outcomes research data
    • Supplements information found in the Prescribing Information
  • Data on File (DOF) Development and Maintenance

    • DOF documents
    • DOF development, review, and maintenance
  • Sales Training Materials Creation, Review, and Delivery

    • Easy to understand
    • Accurate and visually appealing
    • Provides an in-depth description of disease state and product information
  • Scientific Content Translation

    • Accurate and compliant translation of scientific content
    • Native speaker translation from life science professionals
    • Language-specific requests
    • Quick turnaround time
    • Rush services available upon request
  • Drug Monograph Creation

    • Specific to an active ingredient or combination product
    • Information needed for safe and effective use
    • Extension of approved prescribing information
    • Succinct and logical organization allows easy navigation
    • Customizable based on intended application and use setting
  • Managed Care Writing Services

    • Dossiers
    • Clinical executive summaries
    • FAQ documents
    • Medicaid testimonials
    • Slide decks
    • Pharmacy Benefit Manager supporting documents
  • Digital Innovation

    • Multichannel/omnichannel strategies
    • Self-service content/real-time responses
    • Modular authoring
    • Insight tracking and analysis
    • Artificial intelligence
    • Interactive standard responses
  • Component Authoring Support

Our seasoned writers and reviewers possess many years of extensive experience in delivering high-quality, balanced scientific documents, and take pride in adhering to “on-time” delivery. Consisting primarily of PharmDs and PhDs, Med Communications’ writers are proficient in creating scientific expertise content for the pharmaceutical, biotechnology, and healthcare industries. Our clients also benefit from the watchful eyes of our scientific editors, who ensure consistency across client documents, adherence to established style and format, and proper grammar and punctuation.

The Value of Well-Written Scientific Communication

The value of developing scientific content as it relates to the needs of the pharmaceutical industry and the products they market continues to grow. Many of the decisions made by health care providers regarding the use of pharmaceuticals and medical devices regarding their patients’ care comes from information obtained from not only the FDA, but also from colleagues, presentations attended at professional meetings, and other sources of information and recent research findings. This information is imperative for providing the highest level of care for patients.

In the United States, the Food and Drug Administration works with pharmaceutical companies in scheduling product research timelines that may lead to product approval for specific indications, product labeling guidelines, assembling package insert language, the approval of promotional materials and other regulatory guidelines and assistance. Pharmaceutical companies recognize the additional role they must play in keeping drug product information accurate and useful to all segments of health care and consumers. This can be done by working internally or they may outsource some of this work to vendors that employ health specialists who are also medical writers. These vendors are skilled at taking drug product research findings and completing various projects for these organizations. Examples of an increasing number of professional projects provided include:

  • Preparing and periodically revising Standard Response Documents (SRDs) that Life Science Organizations approve for distribution to health care providers
  • Preparing and updating or revising product-specific dossiers which are used to evaluate the use of new pharmaceuticals
  • The preparation of professional slide decks, which may be used for a variety of reasons including sales and marketing meetings as well as internal staff development
  • A critical and compliant review of promotional materials that the company has developed for advertising agencies and the media
  • Assisting companies with different facets of Publications Planning
  • Preparing scientific and nonscientific materials designed for use at professional meetings
  • Writing drafts of publications that are intended for regulatory submission to scientific journals
  • Assisting with other writing projects for which companies identify specific needs

Promotional and Medical Review

The FDA, through the Center for Drug Evaluation and Research (CDER), imposes strict regulations on the pharmaceutical industry for every aspect of the drug development and marketing process for products in the United States. To enforce these regulations, the Office of Prescription Drug Promotion is tasked with ensuring that accurate, fair-balanced, and non-misleading information is presented in Prescribing Information and medical or promotional advertising materials.

As part of the medical, legal, and regulatory (MLR) review process for medical and promotional materials, reviewers must critically evaluate content in written, audio, and video materials for accuracy and compliance with regulatory requirements. They ensure all presented data and claims made about the drug are backed by substantial evidence from clinical trials that are reviewed by the FDA. Specifically, medical review of materials involves taking an in-depth look at values and data points reported in clinical trials to ensure accuracy and consistency across both promotional and non-promotional medical materials. Another critically important goal of medical review is to ensure that all efficacy claims are balanced with appropriate safety information. While the balance between regulatory compliance and the need for effective communication of product information in medical and promotional materials is a delicate one, it can certainly be achieved with the right review services.

Med Communications’ Scientific Content team is highly experienced at collaborating with a wide variety of pharmaceutical clients to ensure that reviewed materials are compliant, comprehensive, and engaging. Our team can serve as subject matter experts who provide strategic day-to-day oversight of medical and promotional materials review operational activities. We are also highly skilled at reviewing with the attention to detail needed to sift through materials that influence the safe and effective use of products and overall patient health.

Med Communications has many years of experience supporting clients with medical and promotional review services. Our review services are classified into three categories that can be tailored to fit your company’s unique needs.

  • General reference review, approval, and formatting: Our team can help support your company and agency partner’s content creation and update activities for medical and promotional materials by reviewing, vetting, and formatting newly added references. This will ensure that the most current references, obtained from high-quality, reputable sources, are presented in all materials according to your standards.
  • Medical quality assurance (QA)/fact check review: Our medical reviewers can actively engage in the MLR review cycle for your projects and focus on the intricately detailed task of fact-checking data points alongside references to ensure accuracy and consistency across all materials. This results in increased efficiency of your MLR review process and significant cost savings for your company.
  • Dedicated medical reviewer: Our dedicated medical reviewer can be seamlessly integrated into your medical team, providing leadership and strategic input for planning and support for all operational activities associated with the medical and promotional materials review process.

Med Communications can partner with you and provide high-quality, dependable review services for promotional and medical materials of your drug products. Contact us to discuss your specific review needs today!

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