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CenterWatch has built a stellar reputation over the past 18 years serving clinical research professionals with hard-hitting journalism, insightful business information and quality analytical and educational content.
CenterWatch medical experts have also provided scientific and regulatory expertise supporting a robust drug intelligence service writing and producing profiles of new drug approvals and summaries of clinical trial results. We have reported on new medical therapies for our patient and healthcare-provider readership, and we have published accredited training manuals for clinical research professionals.
Our reputation for uncompromised quality, adherence to tight deadlines, unprecedented professionalism and inside knowledge is based on years of writing and publishing expertise in a highly regulated environment with diverse and demanding stakeholders.
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CenterWatch Medical Writing Services
Most companies outsource their medical writing needs. Unfortunately, service quality can suffer as many contract service providers treat their medical writing capability as a commodity service characterized by lower cost professionals and frequent staff turnover.
Sponsor companies are now turning to specialty organizations like CenterWatch to produce higher quality documents and provide more experienced and dedicated writers, seamless collaboration, expert project management and effective communications—all the hallmarks of a small, well-run firm. Our size and niche focus on writing and publishing enables CenterWatch to be more flexible, affordable and scalable.
Our Medical Writing Solutions
We provide Medical Writing Solutions for Global Regulatory Affairs and Medical Affairs departments to a select group of sponsor and CRO companies. Our mission is to provide our clients with unmatched expertise, collaborative efficiency, unprecedented quality registration documents and primary manuscripts.
For Global Regulatory Affairs:
- Develop regulatory strategies for preclinical through Phase IV programs
- Develop, write, compile and review regulatory documents (e.g., IND, NDA, BLA, ANDA, IDE, PME, 510(k), CTA, IMPD, eCTD, MAA and DMF)
- Develop CTD documents: Clinical Study Reports, Study Protocols, Investigator Brochures, Informed Consent Forms, Statistical Analysis Plans, Patient Safety Narratives
- Perform QA Audits, due diligence reviews, data verification and development program evaluations
For Medical Affairs:
- Plan comprehensive publications strategy
- Prepare primary manuscripts
- Develop author-initiated review articles
- Prepare abstracts
- Provide guidance for internationalization
- Design and adapt content/format that can be easily customized to meet the language or cultural needs of a specific international location
Our Medical Writers
Our network of medical writers has worked with over 76 life sciences companies, authored hundreds of regulatory documents and has a proven track record of successful regulatory submissions and published manuscripts. You can trust CenterWatch to partner with and support your project teams throughout the registration and publications process.
Our Unique Client Relationships
CenterWatch’s relationships with its medical writing clients achieve an unprecedented level of collaborative quality and work efficiency. Some of the primary characteristics of our unique service offerings include:
- Preferred Relationships with a Select Group of Client Companies:
We establish relationships with a select group of local companies to ensure that our solutions are customized and efficient.
- Access to a Network of Collaborative, Experienced Writers:
We have created a unique and collaborative work environment, termed “ScienceWorks”, that provides support and community to our writers, so they can work at their very best.
- Transparent and Collaborative Planning:
Based on a structured assessment of each project, CenterWatch crafts and adheres to a detailed plan with mutually agreed upon and transparent project execution milestones.
- Internal Benchmarks and 360 Degree Feedback:
CenterWatch applies specific metrics at regular intervals throughout the project, including a mechanism for 360 degree feedback. Mutual expectations of the partnership are clear, deviations are detected and reconciled early and goals are met.
- Beginning-to-End Program Management:
From initial contact through project closure, senior CenterWatch management is involved in every step of the relationship.
- Flexible Integration:
CenterWatch utilizes technology platforms to easily adopt and integrate into client company systems and processes.
- Professional Ethical Conduct:
We set and adhere to the highest ethical standards for professional conduct.
CenterWatch Medical Writing Solutions
Chief Operating Officer