Get in touch with our experts to discuss how we can support your clinical trial, medical writing, & project management needs. Fill out the form to connect today. Contact Us Our experts would love to talk to you about how we can help you. Fill the form and we will get back to you right away. Let's Connect: Please Fill Your Details First Name Last Name Email Message SUBMIT Thanks for submitting! ClaritiDox will get back to you as soon as possible!

Data Privacy Notice ClaritiDox takes data security and privacy very seriously. Since our founding, ClaritiDox has held a strong commitment to data security and privacy. Our comprehensive Data Security and Privacy Program and governance model allows ClaritiDox to rapidly respond to changing needs and regulations to ensure all information assets are protected from threats, whether internal, external, deliberate or accidental. ClaritiDox trains all employees on the importance of privacy and how to handle and manage Personal Information appropriately and securely

Claritidox helps elevate your scientific writing. Master clarity, structure, and style to present research effectively and make a strong academic impact. Scientific Writing Drug development is a complex process that involves rigorous scientific and regulatory writing. For the best understanding and accurate communication of the underlying science, experienced and high-quality writers are of utmost importance. At ClaritiDox, we have over 20 years of writing experience and can support and advise you with all types of documents from preclinical to post-marketing phase. Our writing team is represented globally and has: Senior and above level writers with excellent communication skills, including PhD-level scientists and physicians. A wide range of therapeutic area expertise, including rare disease and gene therapy. Robust understanding across multiple areas of drug development (regulatory affairs, CMC, clinical, nonclinical). Wide expertise on document strategy. Extensive experience in writing documents throughout all phases of drug development. Significant team and project management expertise with the flexibility to easily integrate your company culture. Flexible processes, enabling your company to customize at the program, product, or even document level. The ability to scale the support according to your needs. The resources to provide 24-hour writing support to your projects. Documents we write include the following: Submissions Clinical Summaries and Overviews for INDs, BLA/NDA/MAAs Integrated Summaries of Efficacy and Safety Strategic Regulatory Documents Orphan Drug Designation Pediatric Plans Fast Track Applications Nonclinical Nonclinical Study Reports Nonclinical Written and Tabulated Summaries Health Authority Interactions Briefing Books Regulatory Responses Study-Level Documents Protocols Clinical Study Reports Investigator Brochures Patient Narratives Medical communications Manuscripts Services we provide Submission Leadership At ClaritiDox, we are experienced project and team managers and are fully equipped to support you from small to large scale projects. CONTACT US TO LEARN MORE Strategic Regulatory Writing At ClaritiDox, our writers have exceptional knowledge in multiple therapeutic areas and have led multiple submissions, including some of the first gene therapies on the market. We love to use our experience in meaningful ways. We are uniquely suited to support you with your most challenging projects. CONTACT US TO LEARN MORE Writing Support Our global team of highly experienced writers is available to provide round-the-clock 24-hour writing support to all document types. Any writing task you need, we are available to support you. CONTACT US TO LEARN MORE What our clients say "ClaritiDox is our go-to vendor for our high-profile projects because we trust them to deliver documents that meet our quality standards the first time around. Our timelines are often accelerated, and our study teams have competing priorities; yet, ClaritiDox consistently collaborates with us to meet our goals. They are the one vendor we just don’t worry about.” Director of Regulatory Affairs - Small Biotech HOME SERVICES ABOUT US CONTACT US

Join our passionate team if you have 7+ years of experience in medical writing, transparency, or disclosure. Connect with us today to grow your career forward. Join our Team We are always eager to add to our team. If you have 7 or more years of experience in transparency and disclosure or medical writing and are looking to join a dynamic and passionate community of peers, please reach out through the “Contact Us” form below. At ClaritiDox we are an equal opportunity employer. Would You Like to Join Us? Please submit your information below: First name* Last name Email* Phone Upload Resume* Upload File Message SUBMIT

Specialized data anonymization and redaction services for clinical trials, ensuring compliance with EU CTR, Health Canada, & global data protection regulations. Data Anonymization With the increasing demand for transparency through regulations such as the European Union Clinical Trial Regulation (EU CTR), Policy 0070/0043, Health Canada Public Release of Clinical Information (PRCI), it is crucial to ensure that protected personal data (PPD) and commercially confidential information (CCI) are responsibly redacted and anonymized to prevent the identification of study participants as well as protect CCI. Without adequate support, such tasks can be demanding and lead to error. Our expert team has delivered over 5,500 documents, 30 submissions, and 30 anonymization reports in support of EMA Policies 0070 and 0043, Health Canada, and corporate transparency policies. In our strategic engagements, we work with our clients to ensure appropriate SOP creation and compliance as well as alignment on approach to anonymization. Working with our consultants has the following benefits: Deep understanding of all guidelines and regulations Accelerated redaction turnaround times Significant expertise liaising with regulators Strategy and project management support Anonymization and Redaction Services offered Redaction strategy consultation / risk assessments Preparation of anonymization plans and final reports Data anonymization/redaction services for CTIS, manuscripts, CTgov, Policy 0070, and PRCI Training workshops Anonymization & Redaction Partners ClaritiDox provides tech-enabled anonymization and redaction services when appropriate through our partnerships. What our clients say "We have partnered with ClaritiDox for several years to prepare numerous anonymized clinical application packages for public disclosure. ClaritiDox personnel dedicated to our projects do an impressive job keeping company redaction rules and processes specific to our packages while working across diverse client rules and processes, and meeting or exceeding document preparation timelines. The ClaritiDox team are professional and collaborative and a pleasure to work with.” Associate Director of Disclosure - Large Pharma Company HOME SERVICES ABOUT US CONTACT US