End-to-End Medical Writing Services for Global Clients
CONTINUUM offers high-quality and compliant medical writing services across the entire drug development cycle (preclinical, clinical & commercial). We have expertise across a broad category of therapeutic areas and document types. We also offer medical writing services for medical devices and medical technologies considering the EUMDR & USFDA requirements.
Medical Writing Services:
Clinical Writing:
To support high-quality clinical deliverables that are ICH GCP compliant and scientifically informed
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- ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV
- CSR Synopses for public disclosure
- Investigator Brochures
- Study Protocols
- Patient information & Informed Consent
- Lay summaries
- Patient Brochures
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Regulatory Writing:
To deliver first time-right Regulatory submissions in a timely manner
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- Investigational new drug applications (INDs), new drug applications (NDAs), and common technical document (CTD) submission dossiers
- Regulatory responses
- Clinical and non-clinical overviews
- Summary of product characteristics & core data sheets
- Clinical expert statements
- Briefing documents
- Labelling compliance assessment
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Pharmacovigilance Writing:
To ensure benefit-risk reporting per regulatory and clinical standards
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- Periodic safety update reports (PSURs)
- Periodic benefit-risk evaluation reports (PBRERs)
- US Food and Drug Administration periodic line listings
- Risk management plans (RMPs)
- Development safety update reports (DSURs)
- Local safety summaries (LSSs)
- Signal analyses
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Medical Communications:
To ensure all the commercial objectives have valid scientific relevance
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- Medical communication including manuscripts, conference abstracts/posters, product website content, educational material for HCPs and patients
- Medical marketing reviews and reports
- Slide kits for internal/external communication
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Medical writing for Medical Devices & Medical Technologies:
To address all medical device & technology-specific regulatory writing objectives particularly relevant to EUMDR transition and emerging USFDA guidelines
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- Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, and Summary of Safety and Clinical Performance (SSCP) reports in support of EU MDR compliance, feasibility reports, guided questionnaires, and labeling documents
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Our Services
Dedicated Customer Teams & Agile Services
Our strong team of experts ensures the professionalism, expertize, timeliness & cost efficiency required to ensure that your plans are carried out as needed.