Medical writing is an indispensable piece of the pharmaceutical, biotechnology, and medical device research industries, with the field experiencing significant growth in recent years. In 2022 alone, the market for medical writing was valued at US$3.15 billion, and by 2032, it is expected to double and be worth US$7.95 billion. Medical writers are professionals proficient in scientific research and communication for a variety of target audiences, such as healthcare professionals, regulatory authorities, and patients. Medical writing teams at pharmaceutical companies and contract research organizations (CROs) are experts at developing a diverse array of medical materials, ranging from research papers and regulatory submissions, to clinical trial reports and medical education content.

With the globalization of the pharmaceutical industry and the consequential need for localized medical documents to comply with various regional regulations, many CROs are expanding their clinical trial capabilities to include medical writing. This article will delve into the medical writing services offered by ten of the top CROs worldwide, in no particular order.

Read on to learn how the following companies can support the success of your next clinical trial! 

1. Premier Research

The first on our list of top CROs offering medical writing services is Premier Research, a mid-sized company that is well-recognized globally. Their team is composed of regulatory medical writing experts who have an impressive average of 20 years of experience in the industry. Premier’s medical writing capabilities span the entire spectrum of needs for clinical trials and regulatory document preparation, including the development of study protocols, clinical study reports (CSRs), and patient narratives, amongst other regulatory submission documents. In addition to these core services, this CRO also offers support for marketing applications, complete with associated documents such as Clinical Overviews, Summaries of Clinical Efficacy and Safety, and more. The medical writing team at Premier is a top choice for sponsors because its team is highly knowledgeable about the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines, as well as adhering to the principles of CORE Reference and TransCelerate’s common document templates.

Premier Research offers medical writing services that span several therapeutic areas, including the following:  

• Rare Disease 
• Cell & Gene Therapy
• Oncology & Hematology
• Dermatology
• Neuroscience
• Pediatrics

2. Ergomed CRO

Ergomed is a mid-sized CRO with over 25 years of experience and is a leading provider of extensive medical writing services to ensure the success of any clinical research program. Their medical writing team not only supports pharmaceutical and biotechnology sponsors around the globe, but is also highly experienced, with each member boasting more than 15 years of experience. Ergomed has a proven track record of creating documents compliant with EMA and FDA guidelines, with a strong commitment to staying up-to-date with the latest recommendations and practices. Because of the company’s global reach, its medical writing team can offer a 24-hour service, significantly shortening timelines and making it a reliable partner for urgent projects. Ergomed’s medical writing services span the full development cycle, from clinical to non-interventional and real-world evidence areas, consisting of developing and updating documents such as the following: CSRs, protocols, investigator’s brochures, investigational medicinal product dossiers (IMPD), informed consent forms (ICFs), and many more. Their standalone medical writing services also include consulting, designing studies, and conducting literature reviews.

Examples of some therapeutic areas covered by Ergomed CRO’s medical writing team include the following:  

• Oncology 
• Rare Disease 
• Neurology / CNS 
• Allergy / Respiratory 
• Metabolic Disease 

3. TFS HealthScience

TFS HealthScience CRO is another of our top CROs that offers a wide range of medical writing services, promoting clarity, compliance, and quality in every piece of work they deliver. The TFS Medical Writing team consists of skilled professionals who are not only proficient in multiple languages but also compliant with all ICH guidelines and regulatory requirements around the world. In particular, TFS stands out for the continuity and experience they offer in their medical writing services. A significant proportion of their medical writers have over 10 years of experience, and many have been with TFS for several years, supporting the company’s mission to cultivate successful, long-standing working relationships with clients. Recognizing that clinical trials are incredibly time-sensitive, TFS CRO’s clients can typically expect the first drafts of protocol and CSRs within four to five weeks, with further revisions delivered within five to ten working days after receiving comments. Visit the TFS Medical Writing Services page to learn more about the specific types of documents we can help you with for your next clinical trial!

TFS HealthScience CRO offers medical writing services across the following therapeutic areas:  

• Hematology and Oncology 
• Dermatology, Immunology & Inflammatory Diseases 
• Ophthalmology 
• Internal Medicine 
• Neuroscience 
• Rare Diseases and Orphan Drugs 
• Pediatrics 

4. ICON

ICON is one of the top CROs worldwide known to provide specialized medical writing services to support successful clinical trials. In addition to these services spanning from developing individual documents to extensive medical writing programs, this leading CRO also offers certified translations of all writing deliverables for global projects. Furthermore, the close collaboration between their medical writing team and key operational departments ensures the team delivers highly coordinated results to clients. To maintain organization, each project is assigned a single point of contact throughout the entire writing process to keep sponsors updated on project progress against established timelines. Overall, ICON boasts a global medical writing team with more than 48 writers located in the U.S., the European Union (EU), China, and India, each of whom comes with an average of more than 10 years of writing experience. These qualities, combined with the company’s high retention rate of over 95%, emphasize how ICON consistently provides highly reliable and accurate medical writing services.

ICON CRO’s medical writing team is equipped with the expertise to cover many therapeutic areas, including the following: 

• Cardiovascular 
• Central Nervous System 
• Endocrine & Metabolic Disorders 
• Infectious Diseases 
• Internal Medicine & Immunology 
• Oncology 

5. ethica

Based in Canada, ethica CRO is next on our list of top CROs offering comprehensive medical writing services for clinical trials globally. The company’s overall approach is designed to streamline the review process for all key stakeholders, as well as to minimize the need for drafting burdensome and resource-intensive protocol amendments down the pipeline. In addition to creating clear, regulatory-standardized ICFs, ethica specializes in the development of clinical study protocols. The process begins with detailed planning to identify key elements of a sponsor’s research, including proper population dynamics, study design, and statistical strategy to ensure the final protocol adheres to the highest scientific and ethical standards. Their team of experienced medical writers can deliver clinical trial documents, such as case report forms (CRFs) and CSRs, as well as regulatory documents, such as clinical trial applications (CTAs) and investigational new drug (IND) submissions. As a company, ethica aims to place the research participants at the heart of their medical writing services, ensuring their team is well-informed on North American and European regulatory agency requirements, as well as internationally recognized best practices.

ethica CRO offers an experienced medical writing team for the following therapeutic areas:  

• Dermatology 
• Neurology
• Respiratory Diseases
• Medical Devices 

6. PPD Global

For over 25 years, PPD’s medical writing team has been providing expert support to clinical trial sponsors across various industries, translating complex scientific information into high-quality, regulatory compliant documents. Their deliverables have a wide range of variety, from protocols and CSRs to patient narratives and IND applications. The medical writing team at PPD comprises over 130 writers with an average of 10 years of industry experience, based in over 14 countries, who have collectively completed more than 1000 documents in the last three years. The company also offers customized medical writing solutions, including quality review services, and as well as functional service partnerships, through which they provide efficient and quality services that reduce fixed costs. Overall, PPD understands that every client’s needs are unique, adapting their services accordingly to meet these requirements adeptly every time.

Examples of some therapeutic areas covered by PPD CRO’s medical writing team include the following:  

• Nephrology and Renal Diseases 
• Gastroenterology 
• Hepatology 
• Vaccine Development 
• Ophthalmology 
• Infectious Diseases 
• Urology 

7. Theradex Oncology

Theradex is a specialized oncology CRO that offers extensive medical writing services for this particular therapeutic area while maintaining strict adherence to ICH Good Clinical Practices and the U.S. Code of Federal Regulations. Their experienced medical writing team seamlessly collaborates with medical monitors, scientific experts, and sponsors on a variety of projects within the realm of cancer research. Their wide array of medical writing deliverables includes clinical study protocols and amendments, briefing documents for the Food and Drug Administration (FDA), CSRs, abstracts, journal articles, and much more.

For over 40 years, Theradex has been a notable player in advancing oncology clinical trials, providing central data management and monitoring services for early-phase cancer studies. Since its founding, this niche CRO has expanded globally, now with a strong presence in Europe and through partners in Asia, to deliver personalized service and efficiency with their medical writing team. Overall, Theradex is committed to evolving with advancements in cancer treatment, and its medical writing services reflect the company’s mission to drive the availability of novel treatment options for cancer patients worldwide. 

8. Syneos Health

Syneos Health CRO is another leading provider of medical writing services with decades of expertise that covers 19 therapeutic areas, as well as a wide range of document types. The medical writers at Syneos are not only well-equipped with strong project management and negotiation skills, but they also excel at meeting timelines and reconciling sponsor feedback efficiently. Some of the notable achievements of this CRO’s medical writing team include the completion of 5500 writing projects in the past 3 years, and the publication of 1900 regulatory documents annually. The company also provides flexible solutions for partnering with in-house writers of their clients, offering cost-efficient services that reduce the burden of routine medical writing tasks within a project. It’s important to note that Syneos Health’s medical writing services can be delivered as part of full-service programs or as standalone solutions in a functional service partnership model. Overall, this CRO consistently delivers success in clinical trial projects, ensuring high-quality output with every piece their medical writing team develops.

Syneos Health’s medical writing team is equipped with the expertise to cover many therapeutic areas, including the following:  

• Immunology & Inflammation 
• Cell and Gene Therapy 
• Dermatology 
• Medical Device and Diagnostics 
• Infectious Diseases & Vaccines 
• Neuroscience 

9. Pro Pharma

Next on our list of top CROs offering expert medical writing services is Pro Pharma Research Organization, a CRO that caters to the pharmaceutical and medical device industries, both for human and veterinary research. Their medical writing team is highly experienced with several types of documents, including developing CSRs, regulatory submissions, patient information leaflets, summaries of product characteristics, scientific articles, clinical protocols, and more. As a reputable CRO, Pro Pharma upholds the highest industry standards in all its operations, and its medical writing team is committed to delivering content that is not only scientifically accurate but also compliant with all relevant regulatory requirements. Other unique features offered by the company are its use of proprietary technological platforms, validated questionnaires, and comprehensive frameworks for real-world evidence (RWE). Pro Pharma ensures its medical writing services entail high-quality deliverables for sponsors to enable success for any medical product in every stage of the therapeutic pipeline, from initial development to clinical trials.

Pro Pharma offers medical writing services across the following industries and more:  

• Medical 
• Regulatory 
• Digital 
• Veterinary 

10. Allucent

Last, but certainly not least, we have Allucent, a US-based CRO that is known to offer a wide array of medical writing services to support pharmaceutical and biotechnology clinical trial sponsors. Their skilled and multidisciplinary team of medical writers is committed to maintaining the utmost quality standards throughout the entire process of clinical documentation. The range of documents produced by Allucent broadly includes CSRs, investigator brochures, IMPDs, as well as IND files, manuscripts, and ICFs. The medical writing team at this CRO collectively possesses strong expertise for several regulatory agencies around the world, including the U.S. FDA, Health Canada, and bodies in the EU, United Kingdom, and Asia Pacific. With more than 30 years of experience in over 60 countries, Allucent’s medical writing services have established a reliable reputation for sponsors globally. Overall, the company’s medical writing capabilities consistently prioritize high-quality and personalized customer service, effective communication, and lean project management.

Allucent CRO offers an experienced medical writing team for the following therapeutic areas and more:  

• Oncology and Hematology 
• Rare Diseases and Orphan Drugs 
• Infectious Disease and Vaccine 
• Cell and Gene Therapy 
• Central Nervous System 

Conclusion 

In conclusion, the growth and expansion of industries such as pharmaceutical, biotechnology, and medical device research have led to an increased demand for medical writing services. These top 10 CROs play a pivotal role in meeting this demand, offering a range of services essential for conducting successful clinical trials worldwide.  

About TFS HealthScience CRO 

TFS HealthScience is a global CRO that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our skilled medical writing team is composed of professionals well-familiarized with all ICH guidelines and regulatory requirements worldwide. Visit our website to learn more about the medical writing services TFS can offer for your next clinical trial, or connect with a TFS representative today!