Medical Writing Solutions

Medical Writing Solutions

Offering end-to-end solutions throughout the medical writing journey.

Set-Up

SOPs & Templates: Develop standard operating procedures (SOPs), document templates, and working instructions to ensure your company is compliant with key aspects of GxP.

Budgets & Proposals: In-depth analysis of budgeting strategies, costs, and resources, plus proposal writing services.

Resourcing & Recruiting: Offering talent finder services using our extensive network, with options for onboarding services.

Develop

Training: Building training strategies and delivering virtual, in-person, and eLearning training programmes.

Mentorship: Developing talent to help them fine-tune or expand their skill set.

Doctor using tablet with medical icons.

Deliver

Deliver

Regulatory Writing: for key regulatory documents including IMPDs, investigator brochures, protocols, informed consents and assents, clinical trial/study reports, safety aggregate reports, and more.

Medical Communications: including abstracts, manuscripts, and presentation decks.

Peer Review: offering a high-level, quality peer review of regulatory documents.

Quality Control (QC) Review: performing consistency, grammar, style, and formatting checks of documents.

Plain & Lay Language Writing: providing plain language writing of documents and lay language summaries for protocols and CTRs.

Publishing: for several types of regulatory documents (hyperlinking and bookmarking), and appendices collection and collation. 

Redaction & Anonymisation: CCI and PPD in accordance with EU-CTR and CTIS submission requirements, and data anonymisation in line with Policy 0070.

Other: producing health economics and outreach research (HEOR), and many other document and report types.

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