Company-Sponsored Research Policy Alignment — GPP 2022

Overview

“We sponsor studies, we work with medical writers, and our publication SOP was last updated under GPP3. Legal wants to know whether we follow GPP 2022, and nobody can answer with confidence.” GPP 2022 is the current guideline for the ethical planning, development and publication of company-sponsored biomedical research. It applies to pharmaceutical, biotechnology and device companies and the agencies that write for them; it is not a general requirement for every journal.

NeucitePress audits your current policies and practices against GPP 2022, writes the publication policy, SOPs and templates you are missing, takes them through your medical affairs, legal and regulatory stakeholders, and trains the team to use them.

Who this is for: publications and medical affairs teams at pharmaceutical, biotechnology and medical device companies, and medical communications agencies that produce company-sponsored publications. Journals that receive such submissions can use the same work to set their own policy for handling industry-sponsored papers.

What’s Included

• Gap assessment — review of existing policies, SOPs and practices; requirement-by-requirement mapping to GPP 2022; risk-ranked gap list; benchmarking against industry practice
• Publication policy covering authorship, disclosure, data sharing and transparency
• Authorship guidelines aligned with the ICMJE criteria, with documentation templates
• Disclosure templates for conflicts of interest
• Data transparency framework — data sharing and clinical trial registration guidance
• Publication planning SOP, review and approval workflow, medical writer engagement guidelines and pre-submission quality checklists
• 3-hour training workshop for up to 20 attendees, an implementation roadmap and a quick-reference guide
• Train-the-trainer materials and 90 days of email support after delivery

How It Works

What Stays With Your Editors

Where this work is done for a journal, the journal’s editors keep final authority over reviewer selection, editorial assessment and acceptance of industry-sponsored submissions. Where it is done for a sponsor, the sponsor’s leadership approves and adopts the policies. NeucitePress runs the assessment, drafting, review and training process.

Important Limitations

• GPP 2022 concerns company-sponsored biomedical research. It is not a generic requirement for every journal, and this service is not needed by journals that do not publish industry-sponsored work.
• Policy adoption is your responsibility; NeucitePress drafts, you approve and implement internally. Policies should be reviewed by your legal and regulatory team; this is not legal advice.
• Covers one business unit, therapeutic area or division; enterprise pricing on request.
• Up to 20 training attendees; additional attendees at $100 per person. Refresher sessions at $1,500 per session.
• Project-based. Ongoing compliance monitoring and review of individual manuscripts are separate services.

Common Questions

What changed between GPP3 and GPP 2022?
GPP 2022 expands guidance on data sharing, preprints, plain-language summaries, patient involvement and the roles of professional medical writers. The package addresses all 2022 updates.

Is this appropriate for a medical device company?
GPP 2022 is written for company-sponsored biomedical research generally; the principles apply to device publications with minor scope adjustments.

We are a journal, not a sponsor. Do we need this?
Only if you publish industry-sponsored research and want a documented policy for handling it. Most journals are better served by the ICMJE alignment service or the Editorial Policy Suite.

Every engagement can begin with the Journal Health Check.