Thera-Business

We’re excited to be at the 2026 American Medical Writers Association (AMWA) Medical Writing & Communication Conference in Washington DC! 🌟 It’s been a great opportunity to connect with fellow professionals, share insights, and celebrate the work happening across medical writing and scientific communication. We’re especially looking forward to our CEO, Red Thaddeus Miguel taking the stage this Saturday to present. Stay tuned for more updates from the conference! #AMWA #medicalwriting #therabusiness #conference

AI in Regulatory Writing: Examining critical pitfalls and implications Artificial intelligence is creating new opportunities to improve efficiency in regulatory writing. However, in a highly regulated environment where accuracy, transparency and accountability are essential, its use requires careful consideration. We are pleased to share that our team's latest article, "AI in regulatory writing: Examining critical pitfalls and implications," has been published in the November–December 2026 issue of the RAPS Journal of Regulatory Affairs. The article examines some of the critical challenges associated with AI-assisted regulatory writing. As AI becomes increasingly integrated into regulatory workflows, understanding these risks is essential to ensuring that innovation does not compromise the quality and integrity of regulatory submissions. 📖Read the article abstract here to learn more: raps.org/resource/ai-in-regu… Thera-Business believes that technological innovation must go hand in hand with scientific rigour and regulatory expertise. Contact our team to discuss your regulatory writing needs. Citation: Miguel RTD, et al. AI in regulatory writing: Examining critical pitfalls and implications. RAPS Journal of Regulatory Affairs. 2026;1(6):16-23. Published online 3 November 2026. raps.org/resource/ai-in-regu… #RegulatoryWriting #TheraBusiness #RAPS #AIinHealthcare #ArtificialIntelligence

A CTD is more than a collection of documents. It’s a regulatory story. A Common Technical Document (CTD) can contain all the required information and still leave regulatory reviewers with questions. The challenge often lies in how the evidence connects, how conclusions are supported, and whether the scientific rationale remains consistent throughout the submission. In our latest blog, Dr. Maryam Kamarehei explores why effective CTD preparation goes beyond completeness and compliance. From cross-document consistency and traceability to quality control and cross-functional review, she explains how a coherent regulatory narrative helps reviewers follow the evidence and understand the rationale behind key decisions. 📖 Read the full blog: therabusiness.com/news/Build… Need support with your regulatory submissions? Contact Thera-Business to discuss your regulatory writing and submission support needs. #TheraBusiness #RegulatoryAffairs #CTD #RegulatoryWriting #CommonTechnicalDocument

Systematic reviews do more than summarize evidence. They make better decisions possible. In healthcare, decisions rarely rest on a single study. They depend on understanding the full body of evidence, assessing its reliability, and recognizing where uncertainty remains. In our latest blog, Dr. Pranav Kumar explores how systematic reviews help clinicians, regulators, policymakers, and other decision-makers move beyond individual findings to develop a clearer, more reliable picture of the evidence. Discover why rigorous evidence synthesis is essential to informed, defensible decision-making across healthcare. 📖 Read the full blog: therabusiness.com/news/Syste… #SystematicReview #EvidenceSynthesis #TheraBusiness

This past weekend, Thera-Business was proud to take part in the CHEO Race for the Kids. 🏃‍♀️ We're grateful to have joined a community of participants, volunteers, and supporters working toward a common goal: helping ensure children and youth receive the care they need. Every dollar raised through the event directly supports CHEO and the important work it does for patients and families across the region. Thank you to everyone who participated, donated, volunteered, and cheered from the sidelines. We're proud to support such an impactful cause. 💙 💚 #CHEO #CHEORunForKids #CommunityImpact #TheraBusiness #GivingBack

Small clinical trials face unique challenges — limited sample sizes, recruitment barriers, and higher vulnerability to bias.   Our new joint blog with 3S Pharma explores how AI can help sponsors turn these constraints into strategic advantage through synthetic comparators, adaptive designs, advanced analytics, and fit‑for‑purpose governance.   A must‑read for teams working in rare diseases, early‑phase development, or niche populations.  Read the full blog here: therabusiness.com/news/3S-Ph…

We're pleased to share that our CEO, Red Thaddeus Miguel, will be presenting at the 2026 American Medical Writers Association (AMWA) Medical Writing & Communication Conference in Washington, DC. 📅 7 November 2026 ⏰ 9:00–10:00 AM Session: Meta-Analysis Done Right: Models, Heterogeneity, Bias, and Defensible Conclusions Meta-analyses play a critical role in evidence generation, but their value depends on methodological rigor and transparent interpretation. This session will explore practical approaches for selecting appropriate models, addressing heterogeneity, evaluating bias, and drawing conclusions that can withstand scientific and regulatory scrutiny. If you're attending AMWA, we'd love to see you there! GLOBAL INSIGHT. DIVERSE EXPERTISE. REGULATORY-GRADE EVIDENCE. #AMWA2026 #MedicalWriting #MetaAnalysis #RegulatoryWriting #TheraBusiness

A survey is only as valuable as the decisions it supports. Too often, surveys are viewed as simple data‑collection exercises. In reality, poorly designed surveys can lead to unreliable findings, missed insights, and evidence that cannot withstand scrutiny.📑 At Thera‑Business, we take a different approach. From study design and questionnaire development through data collection, analysis, and reporting, every step of our process is designed to generate high‑quality, regulatory‑ready evidence. By combining a structured methodology with the Qualtrics XM platform, we help clients turn research questions into actionable insights that support clinical, epidemiological, behavioral, and regulatory decision‑making.📈 Because when the right decisions depend on the data, getting the survey right from the start matters. GLOBAL INSIGHT. DIVERSE EXPERTISE. REGULATORY‑GRADE EVIDENCE. #surveys #evidencestrategy #RegulatoryAffairs #TheraBusiness

Thanks to everyone who entered our prize draw and completed our survey at RAPS Convergence! We loved meeting so many of you and truly appreciate the insights you shared. 💙💚 Our winners have now been selected and contacted — congratulations to them, and thanks again to all who took part. 🎁 If you’d like to stay connected with Thera‑Business for future evidence insights and updates, you can explore our survey services or follow our evidence strategy updates visiting our website: therabusiness.com/index.php #RAPSConvergence #RegAffairs #EvidenceStrategy #TheraBusiness

We’ve loved connecting with so many of you in Charlotte, sharing ideas, and chatting all things evidence, surveys, and regulatory affairs. And we’re not done yet! 👋 We’ll be at RAPS Convergence this afternoon and all day tomorrow, so there’s still plenty of time to stop by Booth 1114 and say hello — and don’t forget to take our 2-minute survey for your chance to win one of our prizes! 🎁 We hope to see you there! #RAPSConvergence #RAPS #RegulatoryAffairs #RegulatoryScience #Evidence #Surveys

📍 We’re at RAPS Convergence in Charlotte! Come visit us at Booth 1114 to chat all things evidence, surveys, and more — we’d love to meet you! ✨ Plus, you could win one of our awesome prizes! ✨ Simply take our 2-minute survey at the booth for your chance to enter. It’s quick, easy, and well worth the stop! 👀 We can’t wait to see you at Booth 1114! #RAPSConvergence #RAPS #RegulatoryAffairs #RegulatoryScience #Evidence #Surveys

We’re heading to Charlotte next week for RAPS Convergence 2026, and our team will be on site throughout the conference to discuss evidence strategy, QMS documentation, and regulatory-grade clinical evaluation. If you’re attending RAPS and want to explore how Thera Business can support your upcoming submissions, strengthen your documentation, or streamline your evidence pipeline, we’d be glad to connect. Book a meeting with our team during the conference or stop by Booth #1114 to meet us in person. GLOBAL INSIGHT. DIVERSE EXPERTISE. REGULATORY-GRADE EVIDENCE. lnkd.in/gSu7UAVU

Thera‑Business is thrilled to be exhibiting at #RAPSConvergence 2026 in Charlotte, NC from September 15–17. We’re looking forward to connecting with regulatory professionals, evidence leaders, and innovators across the pharmaceutical, medical device and life science space. If you’re attending RAPS, stop by Booth #1114 to meet our team and explore how we can support your evidence strategy, strengthen your systematic reviews, or streamline your regulatory‑grade documentation. Whether you’re preparing for submissions, building real‑world evidence, or scaling your quality ecosystem, we’d be glad to start the conversation. See you in Charlotte! #RAPSConvergence #RegAffairs #MedicalDevices #EvidenceStrategy #TheraBusiness

Turning survey data into regulatory‑grade evidence takes more than launching a questionnaire — it requires a disciplined, end‑to‑end research process. At Thera‑Business, we support the full survey research lifecycle. From defining research and submission needs to designing the study, programming the instrument, preparing and analyzing data, performing statistical QC, and developing the final evidence package — every step is built for rigor, traceability, and regulatory confidence. Using Qualtrics XM, our team builds and tests surveys with customized routing, validation, and data structures, ensuring clean, reliable data capture. Throughout fielding, we monitor uptake and data quality in real time. Afterward, data are prepared and analyzed using reproducible methods and rigorous statistical quality control before results are incorporated into submission‑ready deliverables. Our end‑to‑end approach creates a clear, defensible pathway from research question to evidence — helping pharmaceutical, medical device, diagnostics, and other regulated companies generate insights they can trust. 👉 If your team needs regulatory‑grade survey evidence, let’s talk. We can help you design, execute, and deliver survey research that stands up to scrutiny. #survey #workflow #qualtrics #therabusiness #evidence #research

Stop by booth #1114 to Win AirPods, Amazon gift cards, or prepaid Visa cards at RAPS! Complete our 2‑minute survey for a chance to win big prizes — including AirPods 4 or a $150 prepaid Visa/Mastercard, plus $100 and $50 runner‑up rewards. Scan the QR code at our booth and enter the draw. See you soon. #RAPSConvergence #Giveaway #TheraBusiness

On Monday, we explored why document control is the backbone of medical device compliance. But strong documentation doesn’t stand alone — it’s part of a broader system that determines whether an organization can consistently deliver safe, effective, and regulatory-grade products. That system is your Quality Management System (QMS). A resilient QMS depends on more than procedures and templates. It requires clear documentation pathways, controlled processes, and consistent evidence practices that ensure every decision, change, and record is traceable and defensible. When document control is strong, the QMS becomes stronger too — enabling teams to reduce risk, streamline audits, and respond confidently to regulatory scrutiny. At Thera‑Business, we help medical device and life science organizations build QMS‑aligned documentation that supports compliance with FDA 21 CFR Part 820, ISO 13485:2016, and EU MDR. From document control to evidence development, our approach reinforces the entire quality ecosystem. If you missed our earlier post, you can check out the blog here: Document Control in Medical Device Quality Management — Why Every Controlled Document Matters. Link: lnkd.in/gY67M67z 👉 Looking to strengthen your QMS documentation or prepare for upcoming audits? Let’s connect. We support teams in building clear, consistent, and regulatory‑grade documentation that stands up to scrutiny. #MedicalDevices #QualityManagement #QMS #ISO13485 #EUMDR #FDA #RegulatoryWriting #DocumentControl #Compliance #TheraBusiness

We are excited to share that Thera-Business will be attending RAPS Convergence 2026 in Charlotte, North Carolina, USA — the premier event for regulatory professionals shaping the future of healthcare. 📍Come visit us in Booth 1114 to explore how our regulatory‑grade evidence, global insight, and diverse expertise help pharmaceutical, medical device and life science teams navigate complex research and compliance challenges with confidence. Want to arrange a meeting in advance? Get in contact today to arrange a time with our team to discuss: · Survey design and data collection for regulatory submissions · Real‑world evidence and HEOR strategies · Post‑market surveillance and systematic reviews See you there on September 15th–17th! #RAPSConvergence2026 #RegulatoryAffairs #MedicalDevices #EvidenceStrategy #TheraBusiness #RWE #HEOR #Compliance #ClinicalResearch

Every controlled document tells a story — of compliance, safety and trust. In medical device quality management, document control isn’t just about managing files. It ensures products are developed, manufactured, and maintained in accordance with regulatory and quality requirements. This structured process involves creating, reviewing, approving, tracking, distributing, revising, storing, and archiving quality documents. When documents are accurate, current, traceable, and secure, teams can move faster, prepare for audits with ease, and strengthen their Quality Management System (QMS). Yet many organizations still face version control issues, manual processes, and inconsistent practices that slow progress. Addressing these challenges requires well-designed documentation and quality processes. That’s where professional regulatory writing makes the difference — transforming documentation into a strategic asset. At Thera-Business, we create documentation that is not only compliant but also clear, consistent, and practical. We believe that investing in strong document control today helps build a resilient QMS that is better prepared for future audits, regulatory updates, and product innovation. 📘 Read more in our latest blog: Document Control in Medical Device Quality Management — Why Every Controlled Document Matters. LINK: therabusiness.com/news/docum… #MedicalDevices #QualityManagement #ISO13485 #EUMDR #FDA #RegulatoryWriting #DocumentControl #Compliance #TheraBusiness

Dr. James Zou, PhD, of Stanford Medicine is helping lead the move toward agentic AI—systems that do more than share information. In a recent conversation, Zou described how AI agents are already being used across biomedical research to: • Refine study ideas and generate hypotheses • Analyze data and investigate potential drug targets • Review manuscripts and suggest ways to strengthen experiments • Work together in virtual laboratories and biotech-style research teams Agentic AI could help scientists explore more ideas and accelerate discovery, but human expertise, methodological rigor, and real-world validation remain indispensable 🔗 Read the full conversation here: med.stanford.edu/news/insigh… #AgenticAI #BiomedicalResearch

What could make the path to a first-in-human trial more efficient? The @FDA is seeking input on a proposed Expedited Investigational New Drug Pilot Program that would connect sponsors with qualified research institutions to develop and review early and late-stage trial protocols. The goal is not to skip essential steps, but to improve coordination while preserving safety and regulatory rigor. 🔗 Read more here: fda.gov/industry/fda-actions… 🎬 And and watch a recent webinar here: youtu.be/Bxrhk5FgKz4?si=Ezlr… #ClinicalTrials #RegulatoryScience