Thera-Business is pleased to announce the publication of a new article, “AI in Regulatory Writing: Examining Critical Pitfalls and Implications,” in the November–December 2026 issue of the RAPS Journal of Regulatory Affairs.
A regulatory submission can contain strong science, complete documentation, and all the expected components of the Common Technical Document (CTD) yet still leave a reviewer with questions. Often, the problem is not what is missing. It is what does not quite connect.
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The importance of a systematic review is not simply that it gathers studies in one place. Its real value is that it makes the evidence more trustworthy, interpretable, and usable when clinicians, regulators, policymakers, and other decision-makers need to act.
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AI is creating new opportunities for sponsors to strengthen the design and analysis of small and medium-sized clinical trials without increasing sample size or cost. In this jointly written perspective from Thera-Business and 3S Pharma, we explore how responsible, fit-for-purpose use of AI can help turn trial constraints into strategic advantages through smarter study design, deeper analytics, and stronger evidence generation.
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A strong medical device Quality Management System (QMS) depends on effective document control. From design and manufacturing to post-market activities, controlled documents help demonstrate that products are developed, manufactured, and maintained in accordance with regulatory and quality requirements.
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Thera-Business is pleased to announce the promotion of Rami Ali to Senior Project Manager, recognizing his leadership across complex international projects, his role in strengthening project-management systems, and his commitment to improving team efficiency while maintaining high-quality client deliverables.
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Thera-Business is pleased to welcome Liu Zhou, MSc, as a Health Research Analyst. Liu brings a strong foundation in quantitative health research and actuarial analysis, with expertise in data validation and statistical modelling to support high-quality health research and regulatory projects.
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Thera-Business CEO, Dr. Red Thaddeus D. Miguel, will take the stage at the renowned 2026 Qualtrics X4 Summit in Seattle to present on how the responsible use of synthetic data can complement traditional methods and expand analytical possibilities in healthcare research.
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Dr. Red Thaddeus D. Miguel will present at the Regulatory Affairs Professionals Society (RAPS) Global Regulatory Strategy Conference this March, contributing to a session on the role of surveys and ad hoc research in post-market performance follow-up.
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Thera-Business welcomes Aliisa Heiskanen, Health Research Analyst. Aliisa brings epidemiology and quantitative health research expertise, with experience in infectious disease and real-world data analysis, strengthening our evidence and insights for clients.
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Thera-Business is pleased to welcome Kathleen Morden to our team as a Health Research Analyst. Kathleen brings a strong foundation in pharmacology and epidemiology to support data-driven health research.
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Thera-Business is delighted to welcome Karen Davtyan to our team as a full-time Programmer/Data Analyst. He joins us after a successful internship with our Survey Team.
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The Thera-Business team will be at AMWA 2025, joining leaders in medical communication for four days of connection and knowledge exchange designed to advance medical communication. We look forward to meaningful conversations with partners and peers.
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Thera-Business authors Red Thaddeus D. Miguel, Manal El Joumaa, and Rami Ali examine the risks of bias in AI-generated medical content and outline practical strategies for medical writers to ensure ethical, equitable communication in the age of AI.
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Thera-Business will be on the ground and on the exhibit floor at the DIA Canada Annual Meeting, October 27–28 in Gatineau, QC, exploring Canada’s evolving regulatory, clinical, and safety and pharmacovigilance landscape.
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The Thera-Business team is excited to attend and exhibit at the DIA Real-World Evidence Conference, delving into the latest advancements and innovative applications of RWE.
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Dr. Red Thaddeus D. Miguel will speak at the DIA Real-World Evidence Conference this October in San Diego, sharing insights on trialing the use of synthetic data, in partnership with research technology provider Qualtrics (Provo, Utah) to advance behavioral health research in special populations.
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We’re pleased to welcome Dr. Maryam Kamarehei to our team as a Medical Writer/Researcher. With deep expertise in biochemistry and an extensive career that bridges academic research and industry, Maryam brings a powerful blend of scientific precision and applied regulatory insight. Her work strengthens our capabilities across pharmaceutical, biotechnology, and public health programs.
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We’re proud to celebrate CEO Dr. Red Thaddeus D. Miguel’s win in the Kellogg College Creative Writing Competition. His poem, Held, explores grief and quiet resilience, inspired by his experience as a young physician.
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Thera-Business is proud to share that our CEO, Dr. Red Thaddeus D. Miguel, a sought-after expert in regulatory science and health research, will lead a roundtable discussion at the American Medical Writers Association (AMWA) 2025 Medical Writing & Communication Conference in Phoenix this November.
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Thera-Business is pleased to announce that our CEO, Dr. Red Thaddeus D. Miguel, will be attending ISPOR 2025, taking place May 13–16, 2025, in Montreal, QC, Canada.
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Thera-Business is pleased to welcome Karen Davtyan to our team. Karen is joining us for the next four months as a Programmer and Data Analyst Intern. With a background in web development, data analytics, and video game development, he brings a strong technical foundation and a creative mindset to the role.
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We are thrilled to announce the promotion of Mrs. Manal El Joumaa to the position of Senior Medical Writer/Researcher. This well-deserved promotion recognizes her outstanding performance, unwavering commitment, and significant contributions since joining the company nearly two years ago.
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We extend our heartfelt congratulations to Dr. Miguel on this well-deserved promotion and look forward to his continued contributions to directing and advancing our mission of delivering exceptional regulatory and evidence-based health research solutions.
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We are thrilled to announce that Dr. Red Thaddeus D. Miguel, our Vice-President and Chief Technology Officer, has been honored as one of this year's recipients of the prestigious Forty Under 40 award from the Ottawa Business Journal and the Ottawa Board of Trade.
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DRUGDOCS® is pleased to introduce a new look. The new portal makes it even easier for healthcare professionals to get the latest drug information they need to make informed, evidence-based decisions.
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We are thrilled to announce the promotion of Mr. Sheldon Yu to the position of Senior Research Analyst at Thera-Business Consulting. Mr. Yu’s appointment to this new role highlights his statistical and analytical expertise, his valued role on our team, and his dedication to Thera-Business, having been with us since 2019.
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It is with great pleasure that we announce the promotion of Mr. Rami Ali to the role of Project Manager at Thera-Business. The appointment to this new position is an indication of Mr. Ali’s exceptional dedication, expertise, and commitment, as well as his invaluable role on our team.
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We are pleased to announce Lindsay Kemp’s promotion into the role of Director of Operations. With over 15 years of invaluable and varied experience in the health science sector, Lindsay is well-equipped to lead the operations of Thera-Business.
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Thera-Business is excited to announce that Ms. Diana Kao, B.Sc., M.Sc., has joined our team as a Senior Health Research Analyst. Ms. Kao received her M.Sc. in Epidemiology from the London School of Hygiene & Tropical Medicine after completing her BSc in Biology at the University of British Columbia. Ms. Kao has 15 years of research experience in both quantitative and qualitative public health/epidemiological studies on infectious and chronic diseases.
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A sister company to Thera-Business, DrugDocs Inc. shares exciting information today about an exciting strategic partnership with the American Medical Women’s Association to raise sex/gender awareness in disease treatment.
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Dr. Isabella Steffensen and Dr. Mimi Kim are delighted to be presenting on the topic of Battle-Tested Strategies for Evidence Synthesis with our partners at Rayyan Systems. Please join us on November 2, 2023, from 12pm to 1pm EST, for this free, interactive webinar.
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Rayyan Systems, Inc. and Thera-Business Inc. proudly announce a strategic partnership to deliver unparalleled evidence synthesis solutions for research organizations and regulated biomedical and healthcare entities.
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I will never forget the words of a mentor who offered me a piece of sage advice that’s reflexively become my go-to when I face a challenge today. I ask myself this one basic question: What are we trying to solve for?
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Imagine you're at the FIFA Women’s World Cup finals and you learn that the average IQ of everyone in the stadium is 102. Now, let's say you decide to estimate this average IQ for yourself. You randomly select 15 batches of 500 people from the stadium ...
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"I had considerable freedom of clinical choice of therapy: My trouble was that I did not know which to use and when. I would gladly have sacrificed my freedom for a little knowledge." (Cochrane, A.L., 1971)
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Thera-Business would like to congratulate Vlad Kuznetsov on his promotion to Director of Software Development. Here at Thera-Business we know that he will continue to excel in this new role. Mr. Kuznetsov has been with Thera-Business since 2020. He has held the roles of Programmer & Data Analyst and Senior Programmer & Data Analyst.
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Thera-Business is pleased to welcome Dr. Isabelle Fakhoury to the team as a Senior Medical Writer. Isabelle joins us with an MSc in Genetics from Paris 7 University, France, and a PhD in Cell and Molecular Biology from the American University of Beirut, Lebanon. She completed her postdoctoral training at ...
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