Clinical trial disclosure services including protocol registration, results disclosure, redaction, plain language summaries, and global compliance strategies. Clinical Trial Disclosure When working with our consultants, you can expect the following: Active monitoring of the global regulatory landscape and understanding of its impact Expert level experience working with registry reviewers Development and implementation of fine-tuning robust, global disclosure programs, including standard operating procedures, style-guides and quality controls Assessment of your current compliance across global registries Strategic consulting and project management Clinical trial registration and disclosure of results in registries such as ClinicalTrials.gov, CTIS/EudraCT, UK, including plain language protocol synopsis and results summaries Disclosure services offered Protocol registration Redaction of study documents XML development Gap analysis & strategy Developing and implementing Disclosure programs, SOPs, and style guides Results Disclosure Plain language authoring General advisory services Workshops Technology and software platforms consultation Disclosure Partnerships ClaritiDox provides tech-enabled services through partnerships with software-providers What our clients say “Moving into my fifth year working with ClaritiDox as a preferred provider in the areas of clinical trial, transparency, regulatory writing, medical writing and anonymization services. I found that the quality of work in addition to the quality of people providing the work is a step above the competition that I've normally dealt with. The team is always very professional, looking to take more responsibility wise, and this has led them to become a trusted partner to externalize and work with. I would highly recommend this team” Head of Clinical Trial Transparency - Large Pharma Company HOME SERVICES ABOUT US CONTACT US

Plain language authoring services to simplify clinical trial info for patients, caregivers, and the public, ensuring better understanding and engagement. Plain Language Authoring Translating complex clinical trial information into plain language is an art form that is critical for the engagement of patients, caregivers, and the general public in the drug development process. At ClaritiDox, we believe in the mission of patient and public empowerment and are eager to support it through the creation of high-quality plain-language summaries. Our team of writers and graphic designers, with a passion for health literacy and numeracy, are experienced in communicating complex concepts in simple and visual terms across a broad range of indications and product types. We are passionate about our plain language authoring services and value the opportunity to translate complex scientific concepts for the public and study participants. Plain Language Services offered Informed consent documents Plain language summaries for clinical trial results Health literacy/patient-panel reviews Plain language protocol synopses Translation services Plain language authoring for web content and patient engagement Plain Language Summary Partners ClaritiDox provides translation, patient panel review, and hosting capabilities through our partnerships. What our clients say “My experience with ClaritiDox has been nothing but positive. Without exception, their writers, QC reviewers, and editors are extremely talented, professional, and experienced. ClaritiDox writers integrate into our study teams seamlessly and not only produce documents of high quality, but also provide guidance and project management, and proactively offer support outside of their assigned documents or projects when needed. Having 24 hour writing and editing support from the ClaritiDox team in other time zones has become invaluable to us, and the quality of their editing and QC is second to none. Any administrative or contract- related issues are resolved quickly and in a friendly and professional manner. I would not hesitate to recommend ClaritiDox.” Senior Director Medical Writing - Mid-sized Pharma Company HOME SERVICES ABOUT US CONTACT US

Document quality control and editing services for pharma, ensuring accuracy, consistency, compliance with regulations, and adherence to style guides. Document Quality Control and Editing Working with us has the following benefits: A dedicated QC team Quick project turnaround A thorough and comprehensive QC and editing review Scientific and regulatory expertise 24-hour editing support Quality, flexibility, and expertise Services We Provide Data consistency against all source documents Line edit, formatting, style, and template checks Compliance with company style guide Internal consistency throughout document sections Reference list confirmation Development and creation of style guides and SOPs 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

A team of proactive regulatory writers with expertise in oncology, rare diseases, and novel treatments. Dedicated to delivering high-quality writing services. About Us Our Mission ClaritiDox is proudly recognized as a public benefit company. We promote business practices that maximize positive outcomes for all our stakeholders: the ClaritiDox team, the industry partners with whom we work, the clients we support, and ultimately the patients our clients serve. The company promotes the responsible sharing of study information for the benefit of patients, researchers, and public health. Our team is our most valuable asset We are a team of collaborative, experienced, dedicated writers, editors, and redactors from a variety of backgrounds. We provide writing services to a discerning group of pharmaceutical, biotechnology, and medical device companies who value our commitment to quality service. We grow with our clients, tailoring our services to meet their needs throughout their programs’ development. We support one another as any good teammate should. We supplement one another’s strengths and build strong, long-term relationships. Our regulatory and disease-specific expertise is continuously expanding beyond our core foundations in oncology, respiratory disorders, cardiovascular disorders, central nervous system disorders, rare diseases, and novel treatment approaches (e.g., pediatric gene therapy). With a commitment to excellence and a focus on open collaboration and generous knowledge sharing, we are eager to join and support teams who share our philosophy. Founder & CEO Kimberly Green Kim is an enthusiastic leader, director-level regulatory writer and consultant with over 20 years of experience. Her writing expertise spans across all areas of drug development with a focus in Clinical Trial Transparency and Disclosure. Kim provides strategic regulatory writing and guidance to multiple clients on T&D activities to ensure compliance with global health authorities. She established a successful T&D service offering, which included registrations and disclosures, redaction services, and plain language summaries. She trained and managed a global team of writers and editors on how to provide T&D strategic writing to Sponsors of all sizes. She has extensive management experience with multi-functional, global teams in the development, authoring, and filing of multiple regulatory documents for eCTD submissions to Food and Drug Administration (FDA), Health Canada, and European Medicines Agency (EMA) as well as T&D deliverables. LETS CONNECT Head of Medical Writing Services Suzi Keating Suzi has almost 20 years of experience in regulatory writing and over 12 years of managerial expertise overseeing large, global teams composed of internal writers and external consultants. She holds a degree in Microbiology and a PhD in Molecular Biology. Suzi has authored and managed the authoring of documents at both program level and submission level and worked across all phases of drug development, from preclinical through Phases 1 to 4 and postmarketing. In 2022, Suzi actively participated in writing and managing the submission of a successful Marketing Authorization Application for Upstaza, the first gene therapy approved for direct infusion into the brain. LETS CONNECT Senior Director of Disclosure Services Brenda Tiffin Brenda has over 33 years of experience in regulatory writing with a focus in Clinical Trial Transparency and Disclosure. She has a strong knowledge of regulatory agency requirements, including EMA Policy 0043, EMA Policy 0070, and United States (US) FDA and International Conference on Harmonization (ICH) standards for safety documents. Brenda leads the team responsible for summarizing and processing clinical trial protocols and results for database disclosure to ensure scientific understanding for the benefit of patients, researchers, and medical professionals. Additionally, she has experience with document redaction and writing anonymization reports, clinical study reports (CSRs), protocols, regulatory responses, modules of the common technical documents (CTD), investigator brochures, and preclinical reports. LETS CONNECT

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