Successful selection of a study site can provide significant benefits to sponsors, CROs, the sites themselves and, of course, patients. But choosing the right site partner is far from simple: It must be suited to the needs of sponsors and CROs, aligning these with their own capabilities and goals. The best fit for some might be choosing […]
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Phoenix, AZ, July 30, 2019 -Another Anju customer benefits from using IRMS (Medical Information) and OpenQ (KOL management solution) connected through the Anju BUS. A successful pharma company launched IRMS as their Med Info capturing system alongside OpenQ, to allow for KOL Engagement tracking and follow up. Combining both solutions allows for the client to link […]
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Mitigating risk to patients in clinical trials is a significant concern for sponsors and researchers. The ultimate pursuit is to find a new treatment, always balanced against the potential harm that can arise in phase I and first-in-human (FIH) trials. While keeping all trial patients safe is of paramount important, treating children requires an even […]
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Whether the headlines are about artificial intelligence or big data, the clinical research industry is undergoing significant change. Many sponsor organizations and CROs have begun their digital revolution, with others trying to catch up. The effect of this change is being felt by patients, of course, set to gain from greater efficiencies, improved data and increased access to treatment. […]
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The DIA 2019 Global Annual Meeting hosted thousands of professionals in the pharmaceutical, biotechnology, and medical device communities from more than 50 countries around the globe and 400+ exhibiting companies. 12 July 2019 by Alexandra Moens | Manager Commercial Operations Data Division Anju Software attended the DIA 2019 Global Annual Meeting in San Diego, California. As DIA […]
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Treating patients as research partners has fast become the goal for many sponsor organizations. This shift towards more patient-centric trials is popular for one reason: it works. Given the recruitment and retention difficulties that beset clinical trials, any move towards improving the patient experience is mutually beneficial to patients and researchers. A vital means to connect and engage with patients is […]
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Clinical trials are expensive. The biggest expense overall is staffing, with patient recruitment a close second. Keeping these costs down is important, and remote monitoring presents an effective means of doing so. There are several added benefits of remote monitoring, one that it provides increased value to patients because it’s easier for them to participate […]
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In partnerships, effective communication is an important element of success. And in the clinical research community, patients suffer when communication fails. This is why it’s so important that sponsors, CROs and trial site staff maintain open, honest and streamlined communication. In this post, we explore what can go wrong when communication breaks down and some […]
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Regulatory submissions for clinical trial sponsors and medical device manufacturers are important moments in the journey to market. The process is time-consuming and allows no room for error. Getting anything wrong at this point can be disastrous for product development. It’s vital then to find the best ways of streamlining the regulatory submission process. In […]
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Every patient enrolled in a clinical trial embarks on a personal journey that typically includes family members. Lizzie Wittig understands that journey. When her mother was diagnosed with breast cancer in 2003, she became her mother’s caregiver and transportation team. Lizzie, who ultimately joined the staff of Susan G. Komen San Diego, recently discussed the details of […]
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June 23-27, 2019 | San Diego, CA At the DIA Annual Meeting 2019, Anju Software is showcasing all its Integrated software and data platforms that connect Clinical Trials, Medical Affairs through Commercialization. Come see a live demo of all our product offerings highlighting the most advanced technologies. See how they all connect! Come visit us at booth #1805 for […]
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Anju’s Clinops team will showcase their services at the PharmaSUG 2019 meeting. Stop by for a live showcase of the ClinPlus – eClinical tools that empower you to accelerate research and reduce compliance risk. BioStats TLF (SAS Based Report Software) gives you the versatility to produce complex statistical summary tables as well as simple data listings, quickly and easily. […]
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The cost of conducting clinical trials is high. And a poor record of patient recruitment and retention, along with the many incomplete or failed studies only add to the financial burden many sponsors carry. Yet there are strategies to help reduce the costs of clinical trials. In this post, we explore what sponsors and research teams […]
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The clinical research community has lately been advocating for a more patient-centric approach to clinical trials. Treating patients as research partners has many advantages, one being that patients will feel valued, which can in turn result in retaining those patients through study completion. Overcoming retention issues in clinical research is ongoing, and putting patients first is a logical means […]
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Anju’s Market Manager for Clinical Insights, Alexandra Moens, was invited by Maruho Co.,Ltd as a keynote speaker at the 66th Yaku-Kon Seminar in Ghent, Belgium. The goal of the seminar was to bring Japanese experts in Europe from several of the global Japanese companies together. This meeting happens once a year and is by invitation only. There were […]
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Offering incentives, often financial, is common practice in many clinical research studies. The rationale is obvious: Patients are more likely to give up their time in exchange for compensation or reimbursement. While debate persists about the ethical implications of enticing patient participation through incentives, another concern is the integrity of study results. This is particularly true […]
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Although paper diaries may be familiar to many sponsors and clinical trial sites, traditional patient journals have the ability to invalidate otherwise reliable and valid clinical trial assessments. That unfortunate scenario can contribute to the ruin of multi-million-dollar clinical trials, depending on primary and secondary objectives as outlined in clinical protocols, which are the main […]
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Innovation, Simplicity, Service Driven – Leads to PubSTRAT’s 2019 Resurgence Phoenix, AZ, April 23, 2019 – Anju Software welcomed 9 new customers to its growing PUBSTRAT customer community in Q1 2019. 4 of which have switched from “industry standard solution” because of the application’s recent technological advancements under Anju leadership. “The PubSTRAT application gives us an […]
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The cost of running a clinical trial is enormous and it’s a well-known fact that recruiting patients is a challenge.Thankfully, the task of hiring staff for clinical research positions is more straightforward, but it’s certainly no less important. In fact, sponsors and CROs require the best possible candidates for their organizations to help ensure the […]
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Adopting a patient-centric approach to clinical research and healthcare has fast become best practice for many — and aspirational for plenty others. This approach requires putting patients first, granting them greater autonomy in their treatment journey and treating the whole person. It’s regarding the last point in particular that integrative medicine (IM) and complementary and […]
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Patients today want greater access to and control of their healthcare data than ever before. They also require the ability to share it with whomever they believe will provide them with tools for better health. Historically, there’s been a reluctance on the part of pharma companies and other healthcare providers to share patient data due […]
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Most industries are engaged in ongoing debates about technology’s ability to improve processes and outcomes. For those working in clinical trials, the discussion holds even greater weight. After all, when trials are made more efficient and cost-effective, patients can reap the benefits. However, the clinical trials industry faces the added concerns of tight regulations and balancing the […]
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“eConsent is a technology-driven, patient-engagement tool that aims to improve site/patient discussions and clinical trial efficiency. It should provide a detailed overview of the clinical trial process in the patient’s own language, while including guided instructions for completing the eConsent and allowing the patient to electronically sign and optionally download the signed consent document. This […]
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April 15-17, 2019 | National Harbor, MD Our Publication Planning team will showcase their services at the ISMPP Annual Meeting. Stop by for a live showcase of the PUBSTRAT Suite – Publication Project Management Application. Ask our team about Online Collaborative Editing Capabilities, Digital Onboarding, Data Visualization/Publication Intelligence Tools and Integration with all major Medical Affairs platforms. […]
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In April, the ta-Scan and Zephyr team will showcase their services at the 17th annual eyeforpharma Philadelphia conference. Curious about our product portfolio expansion for 2019? Then visit us in Philadelphia at booth #318. Or make an appointment with our attendees: info-taScan@AnjuSoftware.com or info-Zephyr@anjusoftware.com. About eyeforpharma Philadelphia eyeforpharma Philadelphia is where 800+ pharma leaders will meet for the world’s greatest gathering of pharma’s value-designers. Are […]
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Precision medicine, as the name suggests, aims to provide tailored treatments to specific subgroups of patients. By studying patients’ specific genetic makeup, as well as the treasure trove of patients’ medical data from analog and digital sources, researchers are becoming better equipped to determine which patients are best suited to benefit from trial drugs. And it’s plain […]
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When then-President Barack Obama signed the 21st Century Cures Act into law in December 2016, he said the legislation would deliver breakthroughs to some of the greatest health challenges of our time. Over ten years, the legislation is set to provide the NIH with $4.8 billion and the FDA with $500 million, along with $1 billion in state grants […]
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According to Edelman’s 2018 Trust Barometer, there’s been a global decline of public trust in the healthcare sector, which includes pharma, biotech, hospitals, insurance and consumer health. This distrust was especially noticeable in established markets including the US and France. In this post we explore points in the clinical trial process at which trust can break […]
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Once you’ve collected reams of data, what are you meant to do with it? It’s a question being asked across many industries and, fortunately, for those operating in the clinical trial market, there’s a relatively simple answer: continue. Keep collecting information from as many relevant sources as possible — but ensure it is processed using […]
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In March, the PUBSTRAT team will showcase Anju’s latest software offering for publication planning industry. Come visit us at the MAPS Annual Meeting 2019 in New Orleans, LA or make an appointment with Kelly Malloy, our Divisional Director: Kelly.Malloy@anjusoftware.com. About MAPS MAPS, a 501(c)(3) non-profit organization, supports the whole function across all different levels of experience/specialty to engage, empower and educate. Tapping into […]
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From industry journals to mainstream publications, the topic of virtual trials is making headlines. For example, virtual trials (Wearable Technology, ePRO and Technology) earned a spot on the Forbes list of Top Five Digital Health Technologies in 2019. Forbes based the ranking on a recent global corporate survey, featuring a single question: “Please indicate the key technology which you believe […]
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PRESS RELEASE Phoenix – February 28, 2019 –Anju Software Inc., a Phoenix-based provider of software and data services to the life science industry has completed a recapitalization with Abry Partners, a Boston-based private equity firm. Abry’s investment will provide capital for continued product enhancement and global expansion and position Anju for market leadership in the […]
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Competition in the established US and European clinical trial markets remains fierce, with pressure on drug developers to beat rivals to market. As a result, many drug companies are looking to emerging markets for abundant and diverse trial populations, lower operational costs and increased opportunities to develop treatments. In this post, we explore why emerging […]
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March 12-14, 2019 | Barcelona, Spain In February, the ta-Scan and Zephyr team will showcase their services at the 17th annual eyeforpharma Barcelona conference. Curious about our product portfolio expansion for 2019? Then visit us in Barcelona at booth #5. Or make an appointment with our attendees: info-taScan@AnjuSoftware.com or info-Zephyr@anjusoftware.com. About eyeforpharma Barcelona 1300+ pharma decision makers from Sales, Marketing, Patient Engagement, Patient Advocacy, Medical […]
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The value of a clinical trial management system (CTMS) cannot be over-emphasized. In short, it is the type of purpose-specific industry technology that contemporary clinical trials cannot do without. And clinical trial staff have come to rely heavily on their chosen CTMS for tasks such as easier site selection, improved data management and greater flexibility in trial design […]
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Sharing clinical trial results and other data, while a relatively new practice in the industry, is a valuable means to improve clinical research. Not only does making data available provide other clinical investigators with information to conduct future trials, it also provides academics with data for research papers and members of the public with key […]
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In February, the PUBSTRAT team will showcase Anju’s latest software offering for publication planning industry. Come visit us at the TIPPA Meeting in San Diego CA . Or make an appointment with our attendees: info-pubstrat@AnjuSoftware.com or Kelly.Malloy@anjusoftware.com. About TIPPA – RISE International Publication Planning Meeting Short timelines, quick deadlines and tight budgets are a constant in the biopharmaceutical industry. Drug development […]
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Focusing on Pharmaceutical, CROs, consultancy companies and other 3rd parties looking to improve their clinical trial efficiency. Phoenix, Arizona, February 12, 2019 – Anju Software Inc. which owns ta-Scan and Zephyr Health, introduces these data solutions, which are used by global pharma companies, in a cost-effective package for Pharmaceutical, CROs, consultancy companies and other 3rd parties. […]
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One of the greatest challenges to achieving clean data in clinical trials is controlling the consistency of terminology. Phoenix, AZ, February 12, 2019 – Anju Software, the leading healthcare technology and analytics platform provider, is pleased to announce the launch of its web-based Coding System. Coding is a powerful tool that enables you to standardize terminology […]
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The healthcare industry is ablaze with high-tech processes including remote monitoring, virtual trials, mHealth and digital health assistants, yet the importance of conferences and trade shows cannot be overstated. Attending these events allows professionals in the field to network in person, learn from other experts, share ideas and pitch products. In that spirit we’ve curated a list […]
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Rare diseases affect around 400 million people around the world, according to the World Health Organization, which defines rare diseases as having a prevalence of one or fewer in 1,000 people. In the US, that’s around 25 to 30 million; in Europe it’s approximately 27 to 36 million, and in India, the estimate is 70 […]
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Nearly three decades ago, in 1989, the FDA introduced non-binding guidelines to make trials more inclusive of older people. Despite this, the elderly remain an underrepresented demographic in clinical trials. Of course, geriatrics are not the only neglected population in clinical trials. Women and minorities remain underrepresented in certain segments too. However, if the industry […]
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n February, the ta-Scan, Zephyr and ClinPlus teams will showcase their services for the first time under the new Anju brand. Curious about our development road-map for 2019? Then visit us at the SCOPE Summit in Orlando at booths #501 and #515. Or make an appointment with our attendees: info-taScan@AnjuSoftware.com or sales-ClinPlus@anjusoftware.com. About SCOPE Summit Celebrating its 10th successful year, SCOPE Summit 2019 takes place February 18-21 in […]
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Preliminary Agenda: Purpose of Moving to Web Web Upgrade Advantage Visual Comparison Internal Planning Project Timeline What’s Coming Up for IRMS/Anju Value Add
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Inclusivity and diversity are being discussed in various areas of society, forcing professionals in many industries to consider whether their working environments reflect these broader social goals. Many in clinical research argue that women, along with ethnic minorities and senior citizens, have been excluded from trials, impacting the validity of the research as well as […]
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Centering on the theme, Scientific Communications in a Fast-Paced World: Fighting Fit for the Future, the 2019 meeting programme will explore ways to adapt our scientific communications and better manage the fast pace of information in today’s world and for the future. Stop by for a life showcase of the PUBSTRAT Suite – Publication Project Management Application. Ask our […]
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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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Trial eligibility criteria are in place to protect patients. A patient with heart problems, for example, would not be able to participate in a trial in which the treatment could pose a risk to that organ. But these criteria also exist to protect the study by excluding participants with conditions that could confound study results. […]
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While there is much excitement about how technology can be used to change the management of clinical trials, some sponsors have yet to take the leap into the tech sphere. On the other hand, many trial planners and managers are using social media to recruit patients and others are looking at using technology to run virtual trials. And when […]
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While awareness of mental health conditions has increased and talking about them has become a lot easier, it remains an area of clinical investigation rife with challenges and controversies. From the perennial problem of poor enrollment to the added issue of gaining consent from the mentally unwell, this post will explore the major challenges that beset mental […]
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The failure to enroll patients and keep them enrolled, the cost of taking a drug to market, the breakdown of relationships between sponsors and trial sites or sponsors and CROs are just some of the threats clinical trials face. It’s important to watch out for these common threats and ensure the trial stays within its […]
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When sponsors and trial planners stress the importance of selecting the correct trial site, they are not understating the gravitas of the task. The wrong site could mean too few patients are recruited, or that it does not align with the needs of the study. Consider research from the Tufts Center for the Study of Drug […]
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With patient safety paramount, the high cost of running trials and the large risk of failure of taking drugs to market, sponsors have historically erred on the side of caution when it comes to clinical trial methods. But this is changing. Indeed, the industry has reached a “tipping point, where the need for flexibility is […]
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The only European forum dedicated to medical information and communications, organised by medical information and communications professionals. Join us and see why IRMS is the industry standard for medical information management software. Visit us at booth #3 or make an appointment with Reed McLaughlin, Vice President of Sales, Medical Affairs: Reed.McLaughlin@AnjuSoftware.com Nov 14, 2018 9:00 AM – Nov 15, 2018 5:30 PM Hotel Savoyen Vienna Rennweg 16 […]
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About 1 in 20 Google searches are health-related and some 72 percent of internet users search online for health information, according to research from John Hopkins University in collaboration with Google. That means devices people use to access the internet for self-diagnoses have become powerful data capturing tools as well as sources of engagement and empowerment for […]
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Join us at the ISMPP West exhibition where we going to highlight new and enhanced features for PubSTRAT, the ONLY publication planning and management system with online document editing and collaboration technology. Kelly Malloy, Divisional Director, will be in the Exhibition Hall to present our PubSTRAT Web Suite. Ask about our Online Collaborative Editing Capabilities, Digital Onboarding & […]
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Developing solid, reliable and lasting relationships between sponsors/CROs and trial sites is essential not only for the positive outcome of a particular trial, but for long-term trend analyses too. However, many past relationships between the two parties could be described as imbalanced with sponsors using their partners once and never again. What is needed instead […]
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Anju Software Harnesses the Power of Life Sciences Data Through Acquisition of Zephyr Health October 2, 2018 NEW YORK – Anju Software Inc., a life sciences software platform backed by Providence Equity Partners, today announced that it has acquired San Francisco-based Zephyr Health, a company that provides comprehensive physician, institution and treatment data for every major […]
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“Patients are invaluable to the clinical trial process,” writes Julia Lakeland for Clinical Informatics News. And, of course, she’s right. Lakeland goes on to point out that one of the major challenges of clinical research is to solve patient recruitment and retention. As a result, many managing researchers are looking for an innovative approach that […]
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CHICAGO–(BUSINESS WIRE)–Anju Software Inc., a life sciences software platform backed by Providence Equity Partners, has acquired the assets of ClinPlus, a division of DZS Software Solutions, Inc. “ClinPlus has a full suite of products used for the performance of clinical trials including EDC, IWRS, CTMS, eTMF, Data Management, Coding and SAS Reporting. With this complete product […]
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Today Anju Software Inc., a life sciences software platform backed by Providence Equity Partners, acquired the assets of OpenQ, a leading provider of Key Opinion Leader (KOL) data base and software solutions to manage KOLs. “OpenQ will enable Anju to provide additional value-added solutions to pharmaceutical and medical device companies. We are confident that this […]
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New York – March 21, 2018 – Anju Software Inc., a life sciences software platform backed by Providence Equity Partners, has acquired the assets of Sylogent. “Sylogent has cloud based state of the art software solutions that enhance current Anju solutions in the Medical Affairs and Clinical Trials space,” said Kurien Jacob, CEO of Anju Software. […]
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June 13, 2016 09:00 AM Eastern Daylight Time CHICAGO–(BUSINESS WIRE)–Anju Software, a life sciences software platform, announced today that it has acquired Online Business Applications (OBA), a global provider of medical communication systems and drug safety compliance software for the pharmaceutical, biotechnology and medical device industries. As part of this transaction, Anju raised funding from Providence Strategic […]
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Anju Software Inc., a life sciences software platform backed by Providence Equity Partners, has acquired Antwerp-based MDCPartners, a company that specializes in business intelligence data solutions for clinical trial optimization, medical expert identification and competitive intelligence. “MDCPartners will enable Anju to provide additional value added solutions to pharmaceutical, biotech and medical device companies. This acquisition […]
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Join the Anju team as they highlight ta-Scan in October at the inaugural edition of SCOPE Europe in Barcelona, Spain. Visit us at booth #6 or make an appointment with our attendees: Alexandra Moens, Account Manager: alexandra.moens@mdcpartners.be Rob Adriaansen, Vice President Sales Europe: robert.adriaansen@mdcpartners.be David Cocker, Chief Scientific Officer: david.cocker@mdcpartners.be Chairperson’s Remarks DAY 1, Tuesday 16 October, 13:55h David Cocker, Chief Scientific Officer, ta-Scan Business Intelligence […]
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This article will look at the relevant arguments to assess current best practice of patient compensation. The FDA, as with many trial sponsors, notes that payment can act as a useful recruitment incentive. However, as referenced in its recent guidance, trials need to have an institutional review board (IRB) look at each case to determine […]
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Conducting clinical trials across multiple countries is becoming increasingly common and useful for clinical research. However, these trials face additional challenges to those that already arise when conducted in a single country. While concerns over logistical constraints and patient attrition persist no matter where a study is held, multinational trials present further concerns based on linguistic, cultural […]
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Increasing diversity in clinical trials is important for reasons such as advancing social justice and building trust with previously underrepresented groups. Diverse trial populations will also lead to more meaningful study results and effective treatments for a greater number of people. In this post, we explore the ramifications of homogenous trials and what recruiters and […]
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As crucial as clinical trials are for pioneering new treatments, it remains a struggle not only to recruit patients, but to keep them enrolled for the duration of the study. In fact, competition for trial subjects grows more intense every year, according to a white paper from InVentiv Health, while regulatory agencies demand that larger target populations undergo […]
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While paper and pen were perfectly adequate means of capturing clinical trial data in the past, the sheer scale and complexity of studies have increased to the point where this is no longer feasible. The obvious solution is implementing electronic data capture (EDC) into an electronic data capture system (EDCS). The benefits are significant and include more […]
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As many as 85 percent of clinical trials are unable to keep patients enrolled long enough to confirm the efficacy of the trial treatment. It’s hard enough to recruit enough patients; losing them before completion is costly in terms of delays and results. The reasons for dropping out of clinical trials are numerous, and some unpreventable. However, […]
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The General Data Protection Regulation (GDPR) came into force on May 25, 2018 after the European Union determined the need for greater data protection of its citizens, and placed more stringent and standardised requirements on how organizations collect and store data. While the regulations are for the EU, there are implications for companies in any […]
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We recently wrote about how implementing a risk-based monitoring (RBM) plan can improve clinical trial performance with clearer data, fewer site visits, lower costs and improved patient safety. Here, we go into more detail about how best to create an RBM plan to enjoy these benefits. What to Do Before Writing the Risk-Based Monitoring Plan […]
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With a move away from source data verification toward risk-based monitoring (RBM), trial sponsors and research teams can reap the rewards of centralized monitoring. In this post, we explore the advantages of an RBM study, what to consider when employing this strategy and how the ICH GCP E6 (R2) Addendum mandates it. Let’s start with […]
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A lot rides on an NDA. All the hard work that has preceded it, along with significant investments of resources and time, makes the submission a watershed moment in every new drug’s journey. Indeed, failure to pass the FDA’s requirements can spell the end for a new drug or at the very least the beginning […]
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While it is not possible in one post to list all the hard-working clinical researchers and medical professionals waging the good battle against cancer, here is a roundup of 10 such individuals. Below, we take a look at the work of these researchers from around the world and wish them good luck and success in […]
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A telling sign of progress is how the language we use to describe processes, people and relationships changes. When it comes to clinical trials, one of the most noteworthy shifts in the words we use is how subjects have become patients. Lindsay Singler, Patty McAdams, Gina Uhlenbrauck, Kirk Jernigan and Julie Schulman at Applied Clinical Trials […]
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My objective was to play counterpoint to the recent LinkedIn blog by Michael Crayne, titled: Why we can’t integrate EMR and EDC and to provoke additional dialogue around this vital topic. However, I just learned the heartbreaking news that Michael passed away last week. So, I hereby dedicate this blog to his wisdom and service […]
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Anju Software’s Chief Innovation Officer Suhas Gudihal and Executive Vice President Mike Keens are featured in IndustryWired. The piece reflects on COVID’s disruptive effect on clinical trial initiations during the pandemic’s early stages and explores the pivotal role that innovative digital technology platforms have subsequently played in transforming and improving the industry. Suhas Gudihal, Chief Innovation Officer, Co-Founder, Anju Software […]
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