Our Community

As the industry rapidly evolves, we continually review the latest developments, standards and guidelines, and best practices through key professional associations and industry groups, including the following:




F E A T U R E S

Industry Organizations

Continuing Medical Education

ACEHP: Alliance for Continuing Education in the Healthcare Professions

Competitive Intelligence

SCIP: Strategic and Competitive Intelligence Professionals

Drug Safety & Pharmacovigilance

ISOP: International Society of Pharmacovigilance

Education and Training

LTEN: Life Sciences Trainers and Educators

Life Sciences & Pharmaceutical Industry

BIO: Biotechnology Innovation Organization
CLSA: California Life Sciences Association
DIA: Drug Information Association
PhRMA: Pharmaceutical Research & Manufacturers of America

Medical Affairs

ACMA: Accreditation Council for Medical Affairs
MAPS: Medical Affairs Professional Society
MSLS: Medical Science Liaisons Society

Medical Writing & Editing

AMWA: American Medical Writers Association
CSE: Council of Science Editors
EMWA: European Medical Writers Association
EASE: European Association of Science Editors
ICMJE: International Committee of Medical Journal Editors
WAME: World Association of Medical Editors

Publication Planning & Development

COPE: Committee on Publication Ethics
EQUATOR Network: Enhancing the QUAlity and Transparency Of health Research
ISMPP: International Society for Medical Publication Professionals
MPIP: Medical Publishing Insights and Practices

Regulatory Affairs

OCRA: Orange County Regulatory Affairs
RAPS: Regulatory Affairs Professionals
Keeping Abreast of the Latest Developments

Open Access White Paper Released

On April 15, 2019, the ISMPP released its new white paper, 
Open Access: A Multistakeholder Discussion on Open Access and Medical Publishing.

Available at: https://www.ismpp.org/open-access-white-paper

Resource Guide: Scientific Communication Platforms

OnApril 3, 2019, the Medical Affairs Professional Society (MAPS) launched their latest resource to guide the Development of Scientific Communication Platforms.

Available at: XXX, but you must be a member of MAPS to access, download, and use.

Standard for Medical Affairs' Role in Launch Excellence

On January 15, 2019, the Medical Affairs Professional Society (MAPS) launched their Medical Affairs Launch Excellence Guidance resource.

Available at: XXX, but you must be a member of MAPS to access, download, and use.

Data Sharing Plan Required in Clinical Trial Registration

As of January 1, 2019, all clinical trials beginning enrollment must include a data-sharing plan in the registration.

Data-Sharing statements must include information on whether the authors intend to share de-identified participant data; what specific data will be shared; what other study-related documents, such as study protocols and Statistical Analysis Plans, will be shared; information on where data will be accessible and to whom; and when and how long the data will be available.

Accreditation Standards for Medical Affairs Professionals

In 2018, the Accreditation Council for Medical Affairs (ACMA) issued their first Accreditation Standards and Key Elements for Professional Development in Medical Affairs for Medical Affairs Professionals.

Available at: https://www.medicalaffairsspecialist.org/wp-content/themes/acma-theme/assets/files/ACMA-Standards.pdf

Medical Science Liaison Guidelines

In December 2018, the MSLS released Version 1.0 of the Medical Science Liaison Guidelines.

Available at: https://www.themsls.org/members-msl-guidelines-download/

Medical Affairs Strategic Planning Guide & Template

OnOctober 24, 2018, the Medical Affairs Professional Society (MAPS) launched their Medical Affairs Strategic Planning Guide and Template, which is designed to be the first in a series of Standards & Guidance documents to be released.

Available at: https://www.medicalaffairs.org/resources/standards-and-guidance/, but must be a member of MAPS to view, download, and use.

Data-Sharing Statement Required for Clinical Trial Manuscripts

As ofJuly 1, 2018,the ICMJE requires all clinical trial manuscripts to include a data-sharing statement.
F E A T U R E S

Key Guidelines & Tools

CONSORT (Consolidated Standards of Reporting Trials)

  • Recommendations for reporting randomized, controlled trials
  • Checklist and Flow Chart

Good Publication Practice (GPP3) Guidelines

  • Recommendations on publication in peer-reviewed journals and oral and poster presentations

PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses

  • Evidence-based minimum set of requirements for producing systematic reviews and meta-analyses

STROBE (STrenghtening the Reporting of OBservational studies in Epidemiology)

Checklist of items to include in articles reporting results of observational studies

TransCelerate Regulatory Document Templates

  • Common Protocol Template
  • Common Statistical Analysis Plan Template
  • Common Clinical Study Report (CSR) Template

CORE Clinical Study Report Reference

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F E A T U R E S

Simple & Powerful

MeSH Subject Headingss

Available at: https://meshb-prev.nlm.nih.gov/search

Readability

Readable.io

RightsLink

Available at: https://academic.oup.com/journals/pages/access_purchase/rights_and_permissions/rightslink

Plain-Language Summary Toolkit

Available at: https://www.envisionthepatient.com/plstoolkit/

Publish or Perish Software

Description at: https://harzing.com/blog/2017/11/publish-or-perish-version-6

Pre-Print Servers

PrePubMed (http://www.prepubmed.org/) indexes preprints from arXiv q-bio, PeerJ Preprints, bioRxiv, F1000Research, preprints.org, The Winnower, Nature Precedings, and Wellcome Open Research. Articles are not stored on PrePubMed, but you will be linked to the article at the respective site.
  • bioRxiv
  • Peerj
  • F1000Research
  • Nature Proceedings
  • Wellcome Open Research Preprint
MedRxiv - The YODA Project
F E A T U R E S

Simple & Powerful

Unpaywall

Available at: https://unpaywall.org/

Clinicaltrials.gov PRS System Templates and Guidance

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Share

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Encrypt

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Notify

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Target

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