PPD Functional Service Partnership (FSP) Medical Writing Solutions
Translate complex scientific data into clear and compliant scientific statements
PPD™ Functional Service Partnership (FSP) Medical Writing solutions help biopharmaceutical, biotech and medical device organizations translate complex scientific data into clear and compliant scientific statements with comprehensive solutions delivered through the flexibility of an FSP model.
Backed by 30 years of FSP experience, we’ve established a proven track record of stable, high-quality medical writing services that deliver the engagement and expertise you need, with the convenience and ease of a single global partner.
Customized medical writing solutions tailored to your unique needs.
Comprehensive medical writing solutions deliver the breadth and depth of expertise you need
Our comprehensive medical writing solutions are backed by a breadth of therapeutic area and document expertise that quickly aligns to your program and regulatory needs.
We cover all facets of medical writing across the development life cycle, including:
- Preclinical: Non-clinical authoring, investigational new drug (IND) modules, annual reports, investigator’s brochures (IBs) and briefing documents.
- Phase I-III: Protocols and amendments, IB updates, informed consent materials, clinical study reports (CSR), CSR narratives, appendices compilation, lay summaries, briefing documents, responses to agencies (e.g., European Union Clinical Trials Regulation Requests and white papers. We also have experts in the Phase IV space.
- Marketing submissions: Marketing Authorization management and authoring for (but not limited to): United States Food and Drug Administration (FDA), Marketing Authorization Applications (MAA) including New Drug Applications (NDA) and Biologics License Applications (BLA), European Medicines Agency (EMA), National Medicinal Products Administration, Pharmaceuticals and Medical Devices Agency (PMDA); biosimilar materials, 120 day updates, large narrative programs, and responses to agencies.
Our specialized medical writing functions assure quality and patient centricity, enabling you to hit the ground running.
- Quality review: Experienced staff in all global locations ensure quality control and compliance with our or client processes on all documents (can be offered as a standalone service).
- Patient-centric writing: Materials incorporate the appropriate messages, tone and grade-level writing to engage patients.
The right talent, expertise and engagement models
Your FSP medical writing team should be built with true experts – Pharm.D., M.D., Ph.D., and master’s level writers – who bring diverse therapeutic backgrounds and long industry tenures to enable a full range of regulatory documentation.
That’s what our PPD FSP Medical Writing solutions team delivers. Our experienced medical writers are problem solvers who excel at translating complex scientific data into clear scientific statements. We produce documents that are scientifically accurate and fully compliant with regulations, industry best practices and client standards.
Close partnership across levels ensures accurate, on-time deliverables
Our structure ensures responsiveness, alignment to your organization’s culture and values, and true subject-matter expertise in your product. We keep our governance model as streamlined and flat as possible to maximize communications and accountability.
Our FSP Medical Writing teams leverage our proven structure to drive efficiency and consistency across the board.
- For every engagement, our assigned medical writing program manager serves as the main point of contact to ensure robust and open lines of communication.
- Lead medical writers have direct communication with client writing teams and experts to ensure efficient and targeted communication.
- We prioritize maintaining a consistent project team, so that allocated writing resources become subject matter experts in your programs – and therefore a seamless extension of your teams.
- Using our asset point of contact (APoC) model, one of our team members becomes a subject-matter expert in one or more products and ensures consistency in messaging across all program documents.
Flexible engagement models to fit your needs
Whether filling specialized gaps in services or providing a large team of medical writers and editors, our engagement is customized to your requirements. We understand that a flexible mix of systems and processes – yours or ours – provides elasticity to rapidly adjust resource levels to keep pace with growth or portfolio changes. We can also work by embedding our medical writing staff within your workforce.
Our innovative pricing models accommodate various contract structures from full-time equivalent (FTE), unit-based, time & materials, and hybrid models. These flexible models can be tailored to evolve with your changing needs over time.
Proven knowledge, experience and infrastructure maximize speed, efficiency and value
The right processes and tools to meet timelines
To ensure our writing and presentation of data is clear and succinct, we favor a lean authoring approach, crafting text that is easy to digest and repurpose into other documents. We proactively leverage tools and capabilities that accelerate document development, enable real-time collaborative reviews, protect data integrity and quality, provide automation options for fully programmed and hybrid narratives, and address disclosure requirements in parallel with protocol and CSR development.
- We use artificial intelligence (AI) to assist with document drafting, reducing time, simplifying complexity and supporting administrative tasks.
- We leverage Veeva Vault RIM and PleaseReview® software to maximize transparency and collaboration and facilitate rapid team consensus and finalization.
- We use robotic process automation: a suite of macros designed to reduce repetitive tasks in Microsoft Word and Veeva.
- We use Programmed in Text Tables to protect end-to-end data integrity and support data quality.
- Our use of PerfectIt® proofreading software supports editorial reviews as a part of standard review practice and is highly customizable for use with client-specific style libraries.
- We offer a specialized medical writing program manager role in a model that encourages partnership thinking, direct contact with essential team members and open lines of communication and reduces the amount of client oversight needed.
- Our EU clinical trials regulation experts address disclosure requirements in parallel with protocol and CSR development.
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Client-specific support for country, regional and global medical writing deliverables
To span all time zones and provide 24-hour coverage to you, we have employees located across the globe – with key locations in North America, the United Kingdom, Europe and Asia-Pacific. Crucial roles are strategically placed in the same time zones as your functional and clinical teams, so our combined teams become a unified group.
With this proven approach, we collectively create successful medical writer teams, encourage knowledge sharing and produce positive, productive interactions throughout the duration of our partnership.
Proven track record across pharmaceutical, biotechnology and government organizations
As the industry grows, so does our experience and expertise.
A diverse range of therapeutic areas supported, including:
- Infectious and respiratory disease
- Neurology
- Oncology
- Endocrine/metabolic
- Musculoskeletal
- Immunology
- Hematology
- Dermatology
- Ophthalmology
- Gastrointestinal
- Psychiatry/psychology
- Cardiovascular
- Genito-urologic
- Women’s health
