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

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 and 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 to 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

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

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

We want the best for your team, your program, and your patient community. Great people matter. Our outstanding team of experienced writers, editors, and redactors is here to support you. Learn More 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. We want to help our clients develop life-changing therapies by providing expert writing, editing, and anonymization services for their research. Who we are A team of Medical Writing and Disclosure experts who are dedicated to our clients’ success. ClaritiDox is headquartered in the US and operates globally. Learn More Our Services Clinical Trial Disclosure Learn More Anonymization and Redaction Learn More Plain Language Authoring Learn More Medical Writing Learn More Consulting Learn More Quality Control & Editing Learn More Project Management Learn More Administrative Services Learn More Testimonials Head of Clinical Trial Transparency large pharma company “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 doubt 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” Senior Director Medical Writing mid-sized pharma company “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 timezones 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.” Associate Director of Disclosure large pharma company “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.” Kimberly Green Founder & CEO Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. First Name Last Name Email Message Send Thanks for submitting! ClaritiDox will get back to you as soon as possible! Contact Us

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