Xtalks Webinar: Driving Outcomes in Medical Affairs — Leveraging Technology to Identify Successful MSL-KOL Relationships

The right key opinion leader or KOL identification — with whom medical science liaisons (MSL) communicate and engage — can transform the effectiveness of the medical affairs and field medical teams. The MSL-KOL relationship can be crucial to successful patient outcomes. Watch this webinar to learn how to move your MSL-KOL relationships from perfunctory to powerful. Join the featured […]

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Why CRO Staff Need Robust Digital Literacy Skills

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Digital literacy skills are no longer merely nice to have. They are essential for navigating daily life, both at home and at work. For contract research organization (CRO) staff members, digital literacy skills need to keep pace with the rapidly expanding world of decentralized clinical trials, which rely heavily on digital tools. CRO teams need these […]

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Xtalks Webinar: Decentralized and Hybrid Clinical Trials — Importance of Interoperability and Partnership

This webinar focuses on the various solutions needed for conducting decentralized clinical trials (DCTs)/hybrid clinical trials, including the interoperable technologies and partnerships required to provide the best patient experience. Watch this webinar for ways to engage and retain patients and the factors to consider for implementing a successful end-to-end solution when evaluating or adopting technologies […]

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During the conference Anju Senior Solutions Engineer, Medical Affairs Division, Steven Anzuini, presented a Hot Topic session titled "Managing Investigator and Internally Sponsored Publications". Anju Software has designed a compliant Approval Request solution within its Medical Affairs software, Pubstrat MAX. With Pubstrat MAX, anyone can easily submit a request to have their data or documents approved before sharing with internal teams or disclosing to the public. Anju’s Approval Request feature enables both internal and external stakeholders to answer a few questions, upload their document, and monitor the status of their request easily and compliantly. Let’s talk about how a compliant request solution can help streamline your organization’s publication approval process.

ISMPP EU: Managing Investigator and Internally Sponsored Publications

During the conference Anju Senior Solutions Engineer, Medical Affairs Division, Steven Anzuini, presented a Hot Topic session titled “Managing Investigator and Internally Sponsored Publications”. Anju Software has designed a compliant Approval Request solution within its Medical Affairs software, Pubstrat MAX. With Pubstrat MAX, anyone can easily submit a request to have their data or documents […]

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Medical Affairs Podcast2021

Life Science Success Podcast

On Wednesday, October 27th, Reed Mclaughlin and Kelly Malloy from Anju Software joined Donald L. Davis on the Life Science Success podcast. The discussion was centered around Reed and Kelly’s perspectives on the evolution of the Medical Affairs function, how it continues to emerge as a strategic pillar within life sciences organizations, and its critical […]

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DIA Med

DIA Med Info Europe: Pre and Current COVID Medical Information Call Center World

The DIA Medical Information and Communications Conference is designed by medical information professionals for medical information professionals, building on a long series of very successful past editions. In this conference, we will leverage learnings on how to improve customers’ experience as they engage with pharma/biotech companies via various touchpoints. We will also explore when and […]

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DIA 2021 Presentation Watch Now

DIA 2021: Utilizing Adaptive Technology Systems to Get the Most from Decentralized Trials

Innovation Theater: Utilizing Adaptive Technology Systems to Get the Most From Decentralized Trials How can you navigate your own challenges in this evolving clinical trial environment? Learn how harnessing technology and data will help your transition from traditional trials to hybrid and decentralized trials. Kim Rejndrup presented jointly with Laura Acosta on “Utilizing Adaptive Technology Systems […]

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Using AI to Formulate Clinical Trial Research Questions

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In clinical research, access to data — and the software to make sense of it — means researchers are better equipped to define their research questions and align various study requirements to optimize results.   By providing improved site selection and recruitment, along with a greater insight into patient populations and their shared traits, AI and machine […]

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Tracking Relationships: Understanding KPIs That Measure KOL Engagement

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Key opinion leaders (KOLs) drive sentiments and behavior throughout the medical community. Medical science liaisons (MSLs) can help KOLs share information and provide high-quality data to better inform them. Tracking KOL relationship-building can be difficult. Many of these connections are based on MSLs’ feelings about the value of a conversation, article, or conference. These feelings […]

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Understanding Security and Role-Based Access in an eTMF Platform

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Most unauthorized data breaches enter through doors that already exist. In its 2021 Data Breach Investigations Report, Verizon estimates that 61 percent of data breaches originate when an unauthorized person uses someone else’s credentials to access information. Once inside the system, a hacker can do damage — but only to the data and resources they can access […]

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Anju Launches New CRO Partner Program

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FT. LAUDERDALE, Fla., December 8, 2022 – Anju Software announced the launch of its new CRO Partner Program. Headed by Mike Loftus, Anju’s Vice President CRO Partner Program, the program provides best value technology and services to Contract Research and Academic Research Organizations as well as Independent and Scientific Research Institutes. “Anju’s CRO Partner Program […]

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Decentralized Trials: Combating Bias and Reaching Diverse Patients

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Clinical trial recruitment remains challenging. Recruiting a sufficiently diverse patient cohort to provide high-quality, representative results remains even more daunting. It’s not just members of minority groups that are underrepresented in clinical trials. Patients who live outside of urban centers and the elderly tend to be marginalized as well. Decentralized clinical trials offer one way […]

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How Big Data and AI Are Changing the Role of Medical Affairs

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Medical affairs teams are growing in prominence in the pharmaceutical and clinical research communities. As more data is available to patients, payers, and physicians, MA teams fulfill a vital role of being a reliable conduit of information.   Indeed, the proliferation of data, the potential of big data, and the advancement of AI all present opportunities […]

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In a Data-Rich Landscape, a Single Source of Truth is Key

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Cloud computing decentralized digital work efforts. In doing so, it gave rise to an era of remote work, telehealth, wearable devices, and other tools revolutionizing clinical trials and work by medical affairs teams. As data decentralizes, however, it raises challenges for knowledge management. Routing data through a “single source of truth” allows teams to access […]

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DMB Conference in Paris This November: Celebrating 25 Years

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The French Association of Biomedical Data Management (DMB) has been a leading professional organization for the pharmaceutical industry since 1995. It aims to bring together data management leaders and CROs from across Europe and beyond. The DMB group is led by 14 individuals elected to two-year terms on a volunteer basis. There is an annual […]

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How Medical Affairs Teams Can Advocate for Patient-Centric Healthcare

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Patient-centric healthcare offers opportunities to improve care, lower costs, and boost patient satisfaction. To date, efforts to integrate patient-centered approaches into clinical trial best practices have been piecemeal at best.   Medical affairs (MA) teams have the skills, perspective, and access to data to improve patient-centered best practices. MA teams can identify communication gaps, analyze […]

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Accurate Clinical Trial Forecasting and Budgeting Strategies

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Anyone who has had to sell a budget proposal knows how challenging it can be. But with the right strategies to forecast clinical trial requirements and accurately calculate the necessary expenditures, trial managers and sponsors can feel more confident in the process.   This post explores some of the best strategies and practices to ensure […]

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Trial Participant Retention

Retaining Trial Participants: Adherence and Dropout Mitigation

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Patient participation is essential to clinical trial success. It is also one of the most challenging parts of running a successful trial.   The problem starts at enrollment: Studies of clinical trial recruitment and retention indicate that only 20 to 30 percent of clinical trials meet enrollment goals, writes David B. Fogel. Then many clinical trial […]

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How Third Party Data Can Improve Clinical Trials

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Big data and data analytics have been adopted across the life sciences and are driving significant industry changes. For clinical research specifically, big data presents possibilities ranging from better patient recruitment and engagement to more efficient trials and better quality results. Given the many sources from which this data is generated, it’s inevitable that trial sponsors and managers […]

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Notable Speakers: DIA Medical Information Conference

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The Drug Information Association (DIA) is one of the top member-driven organizations in the field of life sciences. This organization puts together several events throughout the year, including meetings with leading medical information professionals. On October 5-6, 2022, one such gathering is occurring in Barcelona, Spain: the Medical Information and Communications Conference. This is the premier […]

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Discussing Clinical Trial Performance Metrics with Stakeholders

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Metrics are essential to determine the performance of a clinical trial. However, defining what those metrics are, how to select them, and why they’re valuable is not a straightforward process. Technology used in clinical trials has made standardization of metrics far simpler as data is more easily collected and aggregated. Having standardized metrics makes it […]

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The Role of Medical Affairs in Combating Misinformation

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Our digital world is both good and bad for disseminating information. More information is available at our fingertips than ever before. Publication and dissemination of communications, from memes to scientific studies, can be done more quickly than in the past. It’s because we live in a world where information can be created and shared immediately […]

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Medical Affairs KPIs: How to Create a Framework For Measuring Success

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It’s notoriously hard to quantify a medical affairs team’s impact, even though every innovative healthcare company understands their importance. The challenge is two-fold. On one level, developing a drug or therapy requires the work of many people, and the results of that work sometimes aren’t clear for months, often years. How do you attribute any […]

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Data Interoperability and Sharing: Practical Considerations

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Data interoperability is the name given to this vision. Data interoperability focuses on accessing and processing data from multiple sources. Good data interoperability relies on good data sharing, which comes with its own challenges. Data interoperability and data sharing offer a way to transform clinical trial and medical affairs practices. The dream of a perfectly […]

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Understanding Roles and Needs of Stakeholders in Decentralized Trials

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Technology to support decentralized clinical trials has been developing for several years, but the COVID-19 pandemic pushed decentralized trial use into high gear. Rapid development of decentralized trial methods in 2020 and 2021 has provided a wealth of information — much of it promising. Many clinical trial teams were able to collect at least some […]

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Top KPIs for Measuring Medical Affairs Success in 2022

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Key performance indicators (KPIs) help medical affairs teams track progress and measure success. KPIs also help an MA team demonstrate value when those key performance indicators align with the overall strategic plan. Choosing the right metrics to track can be challenging for MA teams. Medical affairs teams “must track not only the quantitative aspects of […]

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Automation, Analytics, AI and the Future of Trial Monitoring

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High clinical trial failure rates often stem from difficulties in recruiting and retaining patients. A clinical trial may initially suffer from problems in finding and recruiting participants. And once they join the study, patients may drop out if the clinical trial team cannot monitor and coach them effectively. High failure rates, in turn, drive inefficiencies […]

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How a Real-Time eTMF Dashboard Helps Keep a Trial on Track

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Like its paper predecessors, an electronic Trial Master File (eTMF) houses thousands of documents. Each document relates to one of dozens or hundreds of processes that collectively comprise clinical trial work. The fact that this information is essential does not make it any less voluminous. How can clinical trial and medical affairs team members sort […]

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Ease of Implementation and Customization Spell eTMF Success

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Implementing a new software platform can be challenging for everyone involved. For a clinical trial team, software that is easy to use and customized to their needs is a must. Electronic trial master file software enhances the work of clinical trial and medical affairs teams. By focusing on ease of implementation and customization of that software, […]

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World-Class EDC for World-Class Cancer Research Center

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Anju and our TrialMaster EDC partnership with Gustave Roussy have recently been featured in Business Trends Magazine. Business Trends is a paper magazine that offers decision-makers and trend watchers a comprehensive coverage of technological developments and strategic issues in international business across a number of industry verticals. Read on for the full article. Gustave Roussy, one […]

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The Emerging Role of Medical Science Liaisons on Medical Affairs Teams

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One of the most exciting aspects of medical affairs is how the role keeps evolving. New specialists are emerging in their fields and changing how teams engage with key opinion leaders. In the past few years, the number of medical science liaisons (MSLs) has increased. More teams are turning to MSLs to effectively facilitate communication […]

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Global Oncology Community Leveraging Technology for Clinical Trials

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OncologyTube recently interviewed Mike Keens, Anju’s Executive Vice President of Operations, and Stefan Michiels, Head of Department of Biostatistics and Epidemiology at Gustave Roussy. They discussed key aspects of oncology clinical trial enrollment challenges and solutions, especially in light of the COVID-19 pandemic. Watch the full OncologyTube interview with Stefan Michiels and Mike Keens here or scroll down below […]

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Understanding Which KOLs are Key for You

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Key opinion leaders (KOLs) play an essential role in clinical trials and medical affairs. Most KOLs are respected medical experts in their field, known for their ability to converse thoughtfully on nuanced issues. They’re often involved in innovative research of their own, and thus provide informed opinions on others’ research and findings.   Keeping key […]

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What Are The Responsibilities of a Clinical Data Manager and How Have They Evolved?

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The results of a clinical trial are only as good as the data collected from it. Unclean or irrelevant data can lead to incorrect conclusions and endanger patients, not to mention the reputations of clinical research organizations (CROs) and sponsors. In many ways, clinical data managers are the unsung heroes of most trials, tracking what […]

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Mike Keens on Clinical Trials Podcast

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Mike Keens, Aju’s Executive Vice President of Operations, recently was a guest on the Applied Clinical Trials podcast. He joined the discussion with Lisa Henderson and Andy Studna and offers his insights into the current state of decentralized trials, the state of clinical trials technology and the near-future skill sets for clinical trials professionals. Listen to the full […]

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What To Look For in an eTMF

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An electronic Trial Master File (eTMF) platform serves all the basic functions of a traditional on-site TMF space. Yet an eTMF enhances these basic functions and adds new ones, such as the ability to track access and fine-tune security measures.   Not every eTMF will provide the robust support and compliance measures required. Here are […]

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Anju Introduces eTMF Master for Electronic Trial Master File Management

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Cloud-Based, Collaborative Solution Allows Real-Time Management of Clinical Trial Content by Sponsors, CROs and Sites   FORT LAUDERDALE, FL, June 20, 2022 (PRNewswire) –Anju today announced the introduction of eTMF Master, a new cloud-based electronic trial master file software product. The solution facilitates collaboration between sponsors, CROs and sites to efficiently and securely manage clinical […]

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etmf digital solution

Why an eTMF? It’s Time for a Specialized Digital Solution

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Clinical trials generate reams of documents. Many of these documents are produced for specific purposes or audiences. Many are subject to specific requirements that govern everything from the document’s format to the environment in which the document is produced. As documents and their requirements proliferate, so does the burden on clinical trial and medical affairs […]

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Anju CEO Laurence Birch on Price of Business Show

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Recently Kevin Price, host of the nationally syndicated Price of Business radio show, interviewed Anju’s CEO Laurence Birch. The Price of Business is one of the longest running shows of its kind in the country and is in markets coast to coast. The host, Kevin Price, is a multi-award winning author, broadcast journalist, and syndicated columnist. […]

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