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About Us As a team of highly-trained, proactive and experienced regulatory writers from a variety of backgrounds, ClaritiDox currently provides writing services to over 25 pharmaceutical and biotechnology clients. 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. We are invested in our clients’ success as well as our team’s. In addition to being transparency and disclosure and medical writing experts, we are patients, caregivers, parents, and children with aging parents. Within every project, we connect with the study team, discover patient communities, and appreciate the unique opportunity to contribute to development of critical cures. Our team has decades of experience within the field, and we pride ourselves in providing not only the highest quality services but also utmost integrity and longstanding collaborations with our clients. 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. What Defines Us? Highly Experienced, Dedicated Writers & Editors Round the Clock Support Flexibility and Seamless Integration Collaboration and Integrity Our locations Wilmington, US Canada India Portugal Philippines France England Ireland USA Australia Company News Check back soon Once posts are published, you’ll see them here. Interested in Learning More? Get In Touch With Us CONTACT US

Medical Writing: Strategy, Experience and Compliance The transparency and disclosure of clinical trial data is a requirement in many countries and is crucial to build trust and engage patients, clinicians and the pharmaceutical industry in the development of new treatments. As a result, the pressure for sponsors to disclose data is increasing and there are several regulations in place across the globe with which companies must comply. Still, the regulations, policies and guidelines in this field are a continuously evolving landscape, making compliance one of the greatest challenges for sponsors. At ClaritiDox, our team of consultants has been supporting client compliance since the first regulations were published. With years of experience, we offer a deep understanding of the most up to date global regulatory landscape and are uniquely positioned due to our knowledge of processes across Tier 1 to 3 pharma. In addition, our diverse background, which ranges from nonclinical to clinical research, and breadth of therapeutic area expertise, allows us to effectively support a wide range of sponsor goals. When working with our consultants, you can expect the following: Active monitoring of the global regulatory landscape and understanding of its impact Open sharing of their wealth of experience Expert level experience working with registry reviewers Assessment of your current compliance across global registries Development and implementation of fine-tuning robust, global disclosure programs, including standard operating procedures, style-guides and quality controls Clinical trial registration and disclosure of results in registries such as ClinicalTrials.gov, CTIS/EudraCT, UK, including plain language protocol synopsis and results summaries Strategic consulting and project management

Anonymization and Redaction: Strategy, Experience and Compliance The transparency and disclosure of clinical trial data is a requirement in many countries and is crucial to build trust and engage patients, clinicians and the pharmaceutical industry in the development of new treatments. As a result, the pressure for sponsors to disclose data is increasing and there are several regulations in place across the globe with which companies must comply. Still, the regulations, policies and guidelines in this field are a continuously evolving landscape, making compliance one of the greatest challenges for sponsors. At ClaritiDox, our team of consultants has been supporting client compliance since the first regulations were published. With years of experience, we offer a deep understanding of the most up to date global regulatory landscape and are uniquely positioned due to our knowledge of processes across Tier 1 to 3 pharma. In addition, our diverse background, which ranges from nonclinical to clinical research, and breadth of therapeutic area expertise, allows us to effectively support a wide range of sponsor goals. When working with our consultants, you can expect the following: Active monitoring of the global regulatory landscape and understanding of its impact Open sharing of their wealth of experience Expert level experience working with registry reviewers Assessment of your current compliance across global registries Development and implementation of fine-tuning robust, global disclosure programs, including standard operating procedures, style-guides and quality controls Clinical trial registration and disclosure of results in registries such as ClinicalTrials.gov, CTIS/EudraCT, UK, including plain language protocol synopsis and results summaries Strategic consulting and project management

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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

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

We offer clinical trial disclosure, medical writing, anonymization, and project management services, ensuring compliance, transparency, and quality for pharma. Welcome to ClaritiDox! We are so glad you made it! LEARN MORE Who We Are We are a team of scientific writing and disclosure experts who are dedicated to our clients’ success. LEARN MORE Our Services Clinical Trial Disclosure LEARN MORE Anonymization and Redaction LEARN MORE Plain Language Authoring LEARN MORE Medical Writing Consulting LEARN MORE Quality Control & Editing LEARN MORE Project Management LEARN MORE Testimonial “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

Explore our expert services in clinical trial disclosure, anonymization, plain language authoring, medical writing consulting, and quality control for pharma. Our Services Clinical Trial Disclosure LEARN MORE Anonymization and Redaction LEARN MORE Plain Language Authoring LEARN MORE Medical Writing Consulting LEARN MORE Quality Control & Editing LEARN MORE Project Management LEARN MORE

Comprehensive project management and administrative services for pharma, including contract tracking, resource planning, data entry, and workflow management. Project Management Administrative Services Services include, but are not limited to, the following: Contract management and tracking Resource planning Data entry in various systems Workflow management HOME SERVICES ABOUT US CONTACT US

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

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