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

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

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

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

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

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

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