Our engagements range from fully-outsourced support of our clients to individual, ad hoc projects.
On larger engagements, our experts work together with the Sponsor to de-novo establish Transparency and Disclosure and Medical Writing practices, standard operating procedures (SOPs), and internal culture. With individual projects, we fit into the established paradigm to add scale at a critical timepoint.
With an average of 16+ years of experience in regulatory communications, our disclosure experts are at their core regulatory writers with intimate understanding of protocols, statistical analysis plans, and study reports. This knowledge allows our leads not only to create highest quality deliverables, but also to drive out-of-the-box solutions and ensure that all projects end on time and on budget
Our 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.
Speed and accuracy are our foundation. Our partnership with Real Life Sciences enables our consultants to rapidly move through rule set items and advise on precedent for items that are ambiguous or atypical.
Our strategic disclosure consultants actively monitor global regulatory landscape and openly share their breadth of experience and observed precedent with our clients. We have significant experience implementing and fine-tuning robust, global disclosure programs, including development of standard operating procedures, style guides, and quality controls. In addition, our familiarity with existing processes across Tier 1 to 3 pharma allows us to support existing disclosure strategy and quickly jump into individual projects, as needed.
Diversity of staff experience, which includes pre-clinical and clinical research, enables us to effectively support a wide range of Sponsor goals, including posting to the Ukraine Registry.
Our partnership with TrialScope allows us to extend this technology-enabled service solution to our client base.
We believe in the mission of patient and public empowerment and are eager to support it through 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.
Our partnership with TrialScope allows us to provide optional Patient Review Panels, translation services, and online or hard-copy distribution.
Back by popular demand, we do offer traditional regulatory writing and editorial QC support to our clients as stand-alone services. Many of our clients and friends know the skill set of our team members and have specifically requested that we return to our roots for their critical projects. We are happy to keep a foot in this space, as our disclosure services benefit from the diversity of regulatory writing and editing work and keep our analytical skills sharp.
Our medical communications services include abstracts, posters, presentations, publications of clinical trials, and review articles. The ClaritiDox team is skilled at assembling and interpreting scientific and medical data with an eye for detail. Our writers' backgrounds span many therapeutic areas, with particular emphasis in Allergy, Dermatology, Gastroenterology, Infectious diseases, Men’s and Women’s health, Managed care, Neurology, Renal disease, and Rheumatology. In addition, our writers are skilled at preparing disclosures for health economics and outcomes research (HEOR).
Our team has prepared and published hundreds of manuscripts and evidence-based review publications for peer-reviewed journals as well as numerous abstracts/posters/oral presentations for US and international scientific congresses. We also can assist your team with publications plan development to ensure that your data and key messages are available in a timely fashion and your deliverables are high-quality and submission-ready.
Our team is practiced with guidelines for medical publications practices (ICMJE, GPP3, GRDP, Sunshine Act, etc.) and experienced working with document management systems (e.g. Datavision, SharePoint, Veeva Vault, etc.).
We pride ourselves on delivering on-time high-quality work. Let us assist your staff medical writers when the workload is too heavy.
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