Envision Pharma ‘Visions In’ Series

The Envision Pharma Group

An essential part of this process is to develop and provide those companies we partner with our ‘Visions In’ Series of hand-outs. These concise fact sheets offer timely information on the most relevant topics in publication planning.

Each hand-out begins with a scenario followed by a discussion section and key points, and provides a list of additional resources.

The Visions In Publication Series covers the following topics:

  1. Good Publication Practice for Communicating Company-Sponsored Medical Research – GPP2 Guidelines

    Guide to ensure that Publication Committees follow Good Publication Practice for Communicating Company-Sponsored Medical Research (GPP2) so that clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner.

  2. Author versus Contributor

    Guide to ICMJE and the criteria for identifying who received author credit.

  3. Transparency

    Guide to ensuring that contributions & participation by medical writers and other non-author individuals or groups to the development or content of clinical research and other medical and scientific publications are correctly acknowledged, whether originating from commercial, academic, or government research environments.

  4. STROBE Guidelines for Manuscripts

    Guide to help teams proactively assemble all the necessary ingredients for writing a robust manuscript.

  5. CONSORT Guidelines for Manuscripts

    Guide to setting in place a process that seeks to improve the reporting of randomized clinical trials (RCTs).

  6. CONSORT Statement for Congress & Journal Abstracts

    Guide to creating a checklist to help standardize the reporting of clinical trials at congresses.

  7. Will You be Ready?

    Guide to the proper utilization of Datavision™ to allow companies to compile all of the requested information in a single place and report on it as needed and facilitating professionally prepared packages of information to be supplied to any requestor.

  8. Legislative Update: PDUFA/MDUFMA

    Guide to PDUFA IV, which updates PDUFA III, has 2 significant revisions including expanding the types of clinical trials that must register on a public Web site and the creation of a new trial results database.

  9. Is the FDA’s Guidance on Dissemination of Off-Label Data a Shrinking Safe Harbor?

    Guide to provide industry with a way to share appropriate off-label information with healthcare providers.

  10. US Copyright Policy: Sharing of Copyrighted Material

    Guide to US copyright policy and the sharing of such material.

  11. Open-Access Publishing

    Guide to open-access publishing which aims to allow free and unrestricted access to publications via the Internet.

  12. Going Beyond the Primary Manuscript: The Role of Secondary Analyses

    Guide to the role of secondary analyses and additional publication opportunities.

  13. Avoiding “Ghostwritten” Medical Publications

    Guide to ethical and legal issues and roles and responsibilities in medical publications.

  14. Evidence-Based Medicine – How Does it Fit Into a Publication Plan?

    Guide to evidence-based medicine and the publication plan.

  15. Benefits of Using Publication Management Software

    Guide to planning, managing, and tracking publications to prepare for audits, senior management reporting, and addressing external queries.

  16. Journal Selection in a Changing Publication Landscape

    Guide to selecting journals and the publication landscape.

  17. Publication Planning to Ensure Transparency and Manage Risk

    Guide to risk management and prevention.

  18. Publication Team: Roles and Responsibilities

    Guide to defining those responsible for facilitating the timely development of publications.

  1. Publication Planning in a CIA World

    Guide to Corporate Integrity Agreements.

  1. Getting Your Systematic Literature Review Published

    Getting Your Systematic Literature Review Published.

  1. Measuring Success in Publication Programs

    Guide to effective use of metrics.

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