MMS

JUST ANNOUNCED: Our global regulatory and data experts are coming together to present a new webinar titled, “Optimal Strategies to Protect Commercially Confidential Information (CCI) in Clinical Documents and Report Trial Results Under Revised EU-CTIS Transparency Rules.” This webinar sheds light on:  💡 Best practices to be right the ‘first time’ for acceptance of in-scope documents in EU-CTIS submissions. 💡 Recommendations on CTIS submission planning, enhancing process efficiency, and liaising with the agency post adoption of revised rules.  💡 Real-world scenarios and challenges related to non-deferral strategies, CCI protection, and reporting of clinical trial results. Share this post with your network and register here: https://hubs.li/Q02RD3nJ0 #OneMMS #DrugDevelopment #Transparency #CTIS #CCI #Pharma #EMA

October is Breast Cancer Awareness Month! At MMS, we are deeply committed to the fight against breast cancer. As a global leader in oncology drug development, we understand the critical role that innovation and research play in bringing new, effective therapies to patients in need. Breast cancer affects millions of lives each year, and our experts collaborate closely with sponsors to support the submission of new oncology treatments to global health authorities. This month, we stand united with survivors, fighters, and their loved ones, raising awareness and supporting ongoing research. Together, we can continue to push boundaries, innovate, and strive for a future where breast cancer is a thing of the past. #BreastCancerAwareness #Oncology #CancerResearch #DrugDevelopment #ClinicalResearch #OneMMS

The wait is finally over! We are in Boston today for the Society for Clinical Data Management (SCDM) Annual Conference, “The Festival of Opportunity,” and we invite you to visit us at Booth 313. 📍 Our onsite team is here to engage in meaningful discussions about clinical data management and biometrics, explore scientific challenges, and collaborate on solutions that can help de-risk your investments. 🔗 Schedule an on-site meeting now: https://hubs.li/Q02RsWKn0 #SCDM24 #ClinicalDataManagement #Biometrics #Biostatistics #Programming #ClinicalData

Next week kicks off the 12th Annual Arena International Events Group Outsourcing in Clinical Trials Nordics 2024 event! MMS growth has been supercharged in Europe in recent years, outpacing other areas across the globe. As we look to expand our biometrics, regulatory submissions, safety and risk management, and other key CRO solutions, we will be meeting with the pharmaceutical, biotechnology, and medical device communities in the Nordics next week to network and discuss strategies for operational success in clinical trials. Join our experts, Salih (Sal) Siam and Scott Austin, in Copenhagen! Details here: https://hubs.li/Q02Rl3d80 #OCT #DataAnalytics #Biometrics #Biostatistics #ClinicalTrials

Today, Ritchie and Jay will be presenting: "Regulatory Pathways for Nonprescription Drugs: A Deep Dive into OTC Monograph Reform and FDA Guidance!" In this fireside chat, you will learn about the different types of OMORs and how an OMOR differs from a New Drug Application (NDA). Additionally, we’ll discuss suggestions on how to interact with the FDA during the OMOR process to maximize helpful feedback, and provide an overview of the FDA processes outlined in guidance that discusses the format and content of OMORs, timing, and submission packages. Join us at 11AM ET today! Last-minute registrations are still open: https://hubs.li/Q02RbmY80 #OneMMS #DrugDevelopment #OTC #OMOR #Pharma #FDA #CARESAct

Starting a clinical trial is a significant step in advancing medical research, but the success of that trial hinges on selecting the right design! The clinical trial design acts as the blueprint, shaping every aspect of the study, from ethical considerations to endpoint selection and statistical power. Our latest blog post delves into how different designs impact the reliability and interpretability of results. We discuss key factors such as: ✔️ Ethical considerations ✔️ Practical constraints ✔️ Adaptive trial designs. Whether you're in the early phases of research or refining your protocol, understanding these elements is crucial. Read the full blog post here: https://hubs.li/Q02R2vgN0 #ClinicalTrials #ClinicalTrialDesign #MedicalWriting

It is Heritage Day in South Africa, and today we honor and embrace the rich cultures and traditions that make South Africa so unique! Since day one, diversity has been an essential element of the #OneMMS community. Heritage Day provides us with time to reflect on our diverse heritage and the many ways it shapes our identity and community. At MMS, the South African region plays a vital role in our global success, helping drive growth and innovation, as well as contributing significantly to the delivery of exceptional solutions and services worldwide. Please join us in wishing the team well on this special day! #HeritageDay #SouthAfrica #DEI

Today kicks off the DIA Clinical Trial Disclosure & Data Transparency Conference and our session on “Accelerating Clinical Trials Publication by Proactively Protecting CCI: Adapting to EU-CTIS Revised Transparency Rules.” Connect with Mark Bernath and speak with presenter Raina Agarwal, Associate Director of Clinical Trial Disclosure and Transparency at MMS as she dives into: 👉 How to protect CCI in applications 👉 Strategies for safeguarding confidential information 👉 Perspectives on adapting to new CTIS rules This session is a must-attend for anyone looking to stay ahead in clinical trial transparency and regulatory compliance. If you can’t make the event, message us here for a copy of the deck: https://hubs.li/Q02QLfvy0 #ClinicalTrials #Transparency #CCI #DIA2024 #CTIS #Compliance

Our CEO, Uma Sharma, recently visited our Bangalore office, igniting inspiration and passion among our teams. Her meetings with our leaders and candid discussions highlighted our shared commitment to growing our services and expanding our teams. Uma's reflections on "What makes #OneMMS unique and different—our vision and SOUL" resonate deeply with us all. She emphasized that "each of you is an entrepreneur in action," recognizing the incredible work our teams do to empower clients in the development and marketing of life-changing therapies, ultimately making a positive impact on patients’ lives on a global scale. We also had productive discussions during our town hall in Bangalore, with colleagues from India and South Africa dialing in. The energy and insights shared will drive us forward and make Team #OneMMS exceptional.

Are you going to the Society for Clinical Data Management (SCDM) Annual Conference at the end of the month? 📍 Join us in Boston and visit Booth 313 to learn about our: • Deep knowledge and experience in managing clinical data to enhance your trials • Full spectrum of biometrics functions, such as clinical data management, biostatistics, and programming • Advanced solutions such as Datacise® Data Visualization Technology 🔗 Schedule an on-site meeting now: https://hubs.li/Q02QnP4K0 #SCDM24 #ClinicalDataManagement #Biometrics #Biostatistics #Programming #ClinicalData