#clinical trial development

[john-carle123]

Empower the Business Growth with Healthcare Solutions by Codiant

Codiant's network of development teams provides clients with complete, integrated solutions across the whole software development chain in healthcare management software development. Free bug-fixing support following a project

Empower the Business Growth with Healthcare Solutions by Codiant

[omarfor-orchestra]

Just realised I'm actually studying cancer cure

[cbirt]

Researchers from Insilico Medicine designed and devised inClinico to predict Phase-II clinical trial outcomes. The transformer-based artificial intelligence software platform, inClinico, conjugates an ensemble of clinical trial outcome prediction (CTOP) engines that harness generative artificial intelligence and multimodal data that consolidates omics, text, clinical trial design, and small molecule properties. Integrating multimodal data sources, multiple scoring approaches, and biological background along with deep learning models, inClinico software generates a probability of success (PoS) against a Phase II clinical trial evaluation to furnish insight into the probability of Phase II success and, thereby, the transition from Phase II to Phase III. The inClinico CTOP models can be leveraged by the pharmaceutical industries to optimize funding and elevate productivity.

The success of Drug discovery and development is a blessing for civilization, but the expense and involvement of risk in terms of labor, finance, and time; that are associated with the entire process from the pre-discovery stage to marketing are enormous. Computer-aided techniques now ubiquitously complement the pre-discovery and discovery stages.

After that, the clinical trial phase alone takes 6-7 years. Generally, several thousand volunteers are clinically tested with the drug in Phase II. A prior notion about the likelihood of success in the clinical trial is advantageous regarding the effectiveness, the productivity of the R&D department of a pharma company and provides beneficial estimation in cutting down on irrelevant expenses due to failure and further financial investments.

Several attempts have been made to develop artificial intelligence technologies that will foretell whether the clinical trial will be successful. Such works included toxicity prediction through machine learning scoring ensemble based on drug descriptors and target features, drug-induced pathway activation and consequent side effects of a drug, a deep neural network to predict clinical trial outcomes using multimodal data on the molecule tested, etc.

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[intrinsequehealth]

Intrinseque Health - Clinical Supply Chain We Build and Execute Complex Clinical Supply Plans

Intrinseque Health is an EN ISO 13485 Certified Global clinical trial support services provider committed to the utmost in service delivery to drug development organizations (Pharmaceutical, Biotechnology, Medical Device & Contract Research Organizations (CROs)). Our team of industry professionals has over 300 years of combined experience supporting global clinical trials across a wide array of therapeutic areas. This vast experience enables us to empathize with our Customers while providing best-in-class solutions to overcome the hurdles and pain-points of conducting a clinical trial.

Regions & countries throughout the world will often present a unique set of regulatory and logistical challenges. It is our responsibility to understand and overcome these while ensuring that your products, supplies, equipment and services are available where needed to ensure study timelines are met. Intrinseque Health utilizes an operational methodology that is based on proven, cost-effective clinical supply chain strategy for each clinical trial. Our practice is to engage with our customers, early and often to ensure implementation of a robust clinical supply plan, resulting in the most successful study start-up and initiation.

[clinfinite]

Clinical Development Solutions

In the rapidly evolving field of healthcare, clinical development plays a crucial role in bringing novel treatments and therapies to patients worldwide. Clinical Development Solutions (CDS) is at the forefront of this exciting journey, pioneering innovative approaches to accelerate the development and approval of life-saving drugs and medical devices. With a dedicated team of experts and cutting-edge technologies, CDS is committed to transforming the landscape of clinical research and improving patient outcomes.

At CDS, we understand the challenges and complexities of clinical development. Our comprehensive suite of solutions is designed to address these challenges head-on, providing tailored strategies and support throughout the entire drug development lifecycle. From early-phase clinical trials to post-marketing studies, we offer a wide range of services that enable pharmaceutical and biotech companies to navigate the regulatory landscape efficiently and effectively.

One of the key strengths of CDS lies in our expertise in clinical trial design and optimization. We work closely with our clients to design robust and scientifically rigorous trials that generate high-quality data while minimizing risks. By leveraging our extensive knowledge and experience, we can identify the most appropriate patient populations, endpoints, and study designs to maximize the chances of success. Our statistical and data management teams ensure that the collected data is accurate, reliable, and compliant with regulatory requirements.

In addition to trial design, CDS also excels in patient recruitment and retention strategies. We understand the importance of enrolling a diverse and representative patient population to ensure the generalizability of study results. Through our innovative patient-centric approaches, such as digital recruitment platforms and targeted engagement campaigns, we connect with potential study participants and enhance their overall trial experience. By fostering strong relationships with patients and investigators, we improve retention rates and reduce dropout rates, ultimately leading to faster and more reliable study results.

CDS is at the forefront of adopting emerging technologies to drive efficiency and innovation in clinical development. We harness the power of big data analytics, artificial intelligence, and machine learning to uncover valuable insights from complex datasets. These advanced analytics enable us to identify trends, predict outcomes, and optimize trial protocols, thus accelerating the development timeline and reducing costs. Our investment in digital health technologies and wearable devices further enhances data collection and remote monitoring capabilities, enabling more flexible and patient-friendly trial designs.

In the realm of regulatory affairs, CDS provides comprehensive support to ensure compliance with global regulations and standards. Our regulatory experts have in-depth knowledge of regional requirements, including those of the FDA, EMA, and other regulatory authorities worldwide. From preparing regulatory submissions to managing post-marketing safety surveillance, we guide our clients through every step of the regulatory process, ensuring timely approvals and post-approval compliance.

CDS is also committed to fostering collaboration and knowledge sharing within the clinical research community. We organize scientific symposia, webinars, and training programs to facilitate the exchange of ideas and best practices. By promoting interdisciplinary collaboration and staying up to date with the latest industry advancements, we continuously enhance our capabilities and stay at the forefront of clinical development.

In conclusion, Clinical Development Solutions is a leading provider of innovative solutions in clinical development. Through our expertise, technology-driven approaches, and commitment to patient-centricity, we strive to transform the drug development landscape and improve patient outcomes. By partnering with CDS, pharmaceutical and biotech companies can navigate the complexities of clinical research with confidence, bringing new therapies to patients faster and more efficiently. Together, let us shape the future of healthcare through innovation and collaboration.

[clivaldatabase]

What are the different clinical trial opportunities in India?

India holds potential of clinical trials in all the therapeutic segments owing to enriched population diversity, affordable services and increasing health care facilities. Considering the opportunities and challenges described above, the pharmaceutical and biotechnology companies are ready to succeed in clinical trials leading to the constant development of medical science and the provision of better patient treatment. Over the years there has been a dynamic change in the pattern of clinical research; and India has been a key participant in clinical research industry.

[albertyevans]

Know how we helped our client to develop CTMS which helps them to boost research efficiency, ensure compliance & accelerate breakthrough discoveries.

[chemxpert]

Understanding Generic Medicine Industry Insights and Future Outlook

Market Growth: The global generic pharmaceuticals market was USD 7 billion approximately in the year 2022 and it is supposed to grow at a CAGR of 8% for the next coming years. (Courtesy: Deloitte) For this growth, numerous factors are involved like rising approvals of ANDAs and the entry of new generic goods.

[frontropharma]

Bridging Discovery to Delivery: Frontro Pharma's Expertise in Preclinical Studies

At Frontro Pharma, we specialize in facilitating the journey from groundbreaking scientific discovery to life-saving treatments through meticulous preclinical studies. Our dedicated team of research scientists boasts extensive experience across various therapeutic areas, ensuring that your drug development pathway benefits from tailored, high-quality preclinical data. By employing advanced in vitro and in vivo models, we provide detailed insights that enable informed decisions crucial to advancing your drug candidates into clinical development.

[biopharmaceuticalindustry]

The Future of Quality Control: ML Applications in Pharmaceuticals

This article explores the transformative impact of machine learning (ML) applications on quality control in the pharmaceutical industry. It delves into areas such as enhanced data analysis, adaptive quality assurance systems, anomaly detection, resource optimization, predictive maintenance, risk management, personalized medicine, regulatory compliance, collaboration, ethical considerations, and future trends and challenges.

Introduction to ML in Quality Control:

In the dynamic landscape of pharmaceuticals, quality control serves as a pivotal function ensuring that medicinal products meet stringent standards of safety, efficacy, and consistency. As technology evolves, particularly in the realm of machine learning (ML), the future of quality control in pharmaceuticals is being reshaped. ML applications are heralding a new era, promising unprecedented levels of precision, efficiency, and predictive capabilities.

Enhanced Data Analysis with ML

One of the primary areas where ML is making significant strides is in the realm of data analysis. Traditional methods often struggle to handle the vast volumes and complexities of data generated during drug development and manufacturing processes. ML algorithms, however, excel in processing large datasets, identifying intricate patterns, and extracting valuable insights that might otherwise remain obscured. This capability streamlines the analysis process, enabling quicker decision-making and proactive problem-solving.

Adaptive Quality Assurance Systems

ML-driven quality control systems have the remarkable ability to continuously learn and adapt based on real-time data feedback. This adaptability is particularly crucial in an industry where regulatory standards are stringent and continually evolving. By continually refining their algorithms and models, ML-powered systems can stay ahead of potential quality issues, reducing the risk of product recalls and regulatory non-compliance.

Anomaly Detection and Early Warning Systems

ML is also revolutionizing quality control through its capabilities in anomaly detection. Traditional methods often rely on predefined thresholds and rules to flag abnormalities. ML algorithms, however, can detect subtle deviations from expected patterns, even in highly complex processes. This capability enhances early warning systems, allowing for prompt intervention to rectify issues before they escalate, thereby ensuring product quality and safety.

Optimizing Resource Allocation

ML-driven quality control systems play a pivotal role in optimizing resource allocation and production processes. By analyzing historical data and real-time variables, these systems can identify areas for improvement, streamline workflows, and minimize waste. This optimization not only enhances operational efficiency but also contributes to cost savings and sustainable practices within the pharmaceutical industry.

Read more: https://www.pharmafocusamerica.com/articles/future-of-quality-control-in-pharmaceuticals

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[renejix58]

Clinical and Commercial Manufacturing Services in the USA

Renejix Pharma Solutions offers premier clinical and commercial manufacturing services in the USA, ensuring top-quality pharmaceutical solutions for your needs. Call us at +1 (631) 210-5235.

[worldipday]

Can Access to Published Research Help Local Science and Innovation?

Low-cost access to information can drive research and clinical trials in developing economies and contribute to SDGs. But different regions are affected in different ways. So how can low-performing institutions catch up? So far, the public debate on access to medicine, neglected diseases, and patent-protected technology has underplayed the potential of access to information for economic development. Similarly, earlier research has revealed a startling gap between lower- and higher-income countries in terms of access to knowledge, with over half of medical institutions having had no subscriptions to academic literature in lower-income countries.

Several UN agencies and major academic publishers launched the Research For Life (R4L) initiative to fill this gap. The World Health Organization (WHO) runs Health InterNetwork Access to Research Initiative (Hinari), one of fiveprograms under the R4L umbrella. It provides free or low-cost access to academic literature to at least 270,000 researchers in over 100 developing economies. This is for this WHO-led program alone. The entire initiative includes more than 21,000 peer-reviewed journals, 69,000 e-books and 115 data and other sources. Focusing on Hinari, a new WIPO research paper carried out empirical analysis of millions of data points to understand the strengths and weaknesses of the program. It is the first study to link access to scientific publications in developing countries to welfare along the science-to innovation pipeline. The report shows a local increase in health science publications of up to 75% after joining Hinari. Likewise, involvement in international clinical trials grew by over 20%, suggesting that research and innovation in local institutions improved. Screening over 36 million scientific papers in PubMed, a repository of health science, the study found more than 167,000 papers coauthored by local researchers in developing economies, which cited clinical trials conducted worldwide over 30 years.

However, this uptick in science publishing and clinical trials only partially translated into global patents and inventions. The study attributes this to developing countries often lacking infrastructure and funding to transfer new findings into patented technologies. This gap reveals the remaining challenges in developing innovation and IP systems. Moreover, the study also finds that local context matters. Institutions in specific regions and those that already had a high research performance benefited most from the Hinari program. This also means that it is harder for others to catch up, despite better access to information.

Access to global knowledge counts on the ground Empowering local researchers by providing access to information is essential to their work. Researchers tend to target diseases that affect the local population and may be overlooked by researchers abroad. Enabling such access may help innovation in neglected diseases, mainly by connecting local teams to the global knowledge base. Aside from increased scientific activity, R4L also reports direct effects from Hinari regarding medical practice and patient care. The initiative quotes Dr. Nguyen Duc Chinh from Viet Duc Hospital, Hanoi, Viet Nam: “Good research, in short, leads to better patient care.” The doctor relied heavily on Hinari for his PhD on intestinal TB and surgical treatment. TB is prevalent in Viet Nam, but there is a relative lack of information on intestinal TB. “With the information and knowledge we obtain,” he says, “we feel more confident in practicing and implementing respected medical expertise from around the world.” Dr. Sami Hyacinthe Kambire at Kamboinsé Research Station, Ouagadougou, Burkina Faso, also found his research progressing faster and wrote grantwinning funding proposals thanks to Hinari. Before his institution adopted R4L, Dr. Kambire often devoted considerable time to research already

performed elsewhere. The initiative helped reduce these duplicative research efforts in global health sciences and increase the quality of local teaching and education.

Access to information affects institutions differently Despite the impacts, the study also found that the program effects differed for different parts of the world. Research institutions in the Carribean, Central Asia, Europe and Latin America benefited the most in generating new scientific knowledge. On average, their academic paper output increased by 80–100%. Regarding clinical trials, program participation is most impactful for East Asia, the Pacific, the Middle East and North Africa. Trial activity rose by up to 35% at institutions in these regions. That does not mean other regions did not gain from the program, but the impact has been less pronounced.

However, there are also institutional differences. Notably, the study authors wanted to avoid comparing apples to oranges, because high- and low-performing research institutions differ. The high performers might be more likely to adopt the Hinari program in the first place. Seeing more publications might also be an outcome of the institutionsʼ selection into the program rather than an outcome of the program and better access to knowledge on the ground. To reveal the causal effects rather than mere correlations, the study compares different fields. This means health sciences supported by the program are matched against other research fields not supported by Hinari but conducted at the same institution.

How to make the most of access to information Having ruled out the factors described above, the report suggests that program management could improve in two ways. First, it shows that already productive institutions benefit more from Hinari. For example, research institutions that have previously published academic papers see an average 60–70% increase in their publications after joining. This increase is only around 40% for institutions that rarely published scientific works previously. This suggests that Hinari preserves the gap between the most and least productive institutions for scientific publications and clinical trials. Under these conditions, the least productive institutions are, all else being equal, less likely to catch up. Still, the study ultimately supports the view that the Hinari program and the R4L initiative contribute to achieving the SDGs. They help boost research and innovation capacity in developing economies and improve health services (SDG 3) and education quality (SDG 4) at local institutions. They also aim to build industry, innovation and infrastructure, thus encouraging decent economic growth (SDGs 8 and 9).

The R4L initiative is also an excellent example of how private–public initiatives can make a difference. It joins private sector stakeholders from the global publishing industry and research institutions in the UN member states in a win–win situation. For research institutions, the initiative provides a practical solution. Their libraries and labs often need to be better resourced, and R4L improves access to information for students and researchers. It is also a smart way for industry stakeholders to show their corporate social responsibility and enhance their social impact in developing economies. It could also help grow local demand and the customer base in the long term. Moreover, easing access to published research through initiatives like Hinari and WIPOʼs Access to Research for Development and Innovation (ARDI) program can significantly affect research output and contribute to desired social and economic outcomes laid out in the SDGs. UN agencies like the WHO and WIPO have been vital matchmakers. However, addressing existing gaps through schemes such as WIPOʼs Technology and Innovation Support Centers (TISCs) may help build local infrastructure and contribute to a vibrant IP and innovation system. In conclusion, the reportʼs findings on success and remaining challenges may inform stakeholdersʼ decisions to renew or change their commitment to R4L beyond 2025.

[foodresearchlab]

Owing to immense pressure on biotech companies to decrease the turnaround time, increase cost effectiveness, India is increasingly becoming a suitable place for carrying out clinical trials owing to its large human resource and technical expertise.

Visit Now >> https://www.foodresearchlab.com/blog/india-popular-destination-for-clinical-trials/ For Enquiry United Kingdom: +44 – 161 818 4656 India: +91 9566299022 info@foodresearchlab.com

[fernsweb]

Clinical Trials and Drug Development Process

We asked an experienced physician for a solid opinion on needed improvements in the clinical space and pharma’s pursuit of licensed drugs. Dr Kenyatta Cosby, MD, provided us with this perspective. He is a seasoned and published practitioner with many successful and highly-regarded trials under his belt – and someone who definitely understands the strategic and operational pursuits of the drug development process. We are proud to have Dr Cosby provide his expert opinion on today’s clinical climate and opportunities to streamline the drug development pipeline

Dear Colleagues,

If you are a pharmaceutical executive, senior health administrator, or public policy-maker, please indulge me for a moment to be reminded that continued investments into innovative ideas are what’s needed in order to transform current challenges within the drug-development and randomized clinical trial (RCT) process. For decades, scientific and business-centric stakeholders have struggled to produce a pathway that enables the transformation of intuitive workflows, advanced analytics, and smart devices (i.e., cloud-based connectivity) into a robust pipeline for discovering blockbuster medications like Keytruda1, Humira2, Eliquis3, Opdivo4, and Imbruvica5.

New vaccine operations being implemented by leading drug-makers and the federal government in response to the global COVID-196 pandemic have offered renewed hope about a new logistical framework to help accelerate RCT. Surprisingly, it was only in 2014, when a widely-held therapeutic reality was published in _the New York Times_7 which suggested that fewer blockbuster drugs were being produced and the financial requirements for a novel drug to enter the therapeutic marketplace in the United States was becoming too costly.

Today, however, the good news is that the former is no longer true; drug makers are now seeking more novel drug approvals8 from the Food and Drug Administration (FDA)9. The automation of many operations and the creation of specialized workflows via biometric and RFID enabled smart devices had a lot to do with integrating biotech labs with commercial organizations. Unfortunately, the part about high costs still holds, and in some regards is getting worse. A new study published by a team at MIT Sloan School of Management and the Laboratory for Financial Engineering10, suggests that the current cost to bring a new drug to the market is estimated to be as high as $2.8 billion11, with two-thirds of this cost going to the clinical trial process, and 90%12 of these trials failing.

Notwithstanding these hard facts and other frustrations throughout the drug commercialization process, there is an emerging consensus by key stakeholders to bet on leveraging artificial intelligence (AI)13 and machine learning capabilities to ensure scientific integrity and contain cost over time. Some of the newest platforms utilizing this technology are geared towards “site-less” clinical trials14 and the acceleration of time needed to receive FDA-approval. A leader in this space is Janssen Clinical Innovation (JCI)15, part of Janssen Research & Development, LLC.

JCI has demonstrated notable successes with clinical initiatives such as their utilization of direct-to-patient and real-world data platforms. Key examples of their business platforms are a large-scale observation and treatment program, mSToPS16 (short for mHealth Screening To Prevent Strokes), the use of digital technology to decrease paperwork and logistical challenges (i.e., eConsent17, registrational clinical trial18) and  iSTEP19 (short for Integrated Smart Trial & Engagement Platform).

However, when it comes to making a significant change at the individual level and maximizing the workflow within a 24-hour work cycle, P360 is a clear leader in this space. They specialize in robust clinical trial management systems, which are easy to integrate and produce a seamless flow of functionality across operations (i.e., start-up, enrollment, execution, and tracking). P360’s most revolutionary tool is Curotrak, which is a cloud-based trial management software suite that allows the clinician centralized safeguards over multiple programs in terms of processes and data safety involved with planning, implementation and closeout activities. These innovative tools provide a broad change in the traditional clinical trial approach that gives corporations a customer-focus within regulatory guidelines. 

To my knowledge, the current COVID-19 RCTs are focus on five clinical stages of the disease process: Pre-exposure prophylaxis, Post-exposure prophylaxis, Hospital admission, Late-stage critical care and Outpatient treatment. The outcome data for each area has been promising, but there is still a need for caution given that various studies have only demonstrated incremental reductions in patient mortality. This is where innovative solutions like Swittons, an loT powered smart device by P360, can use advanced analytics and AI deployment via automated messaging and push/pull data streaming to accelerate sales operations for pharmaceutical organizations. It is these types of solutions that will ultimately enhance commercial value to the “customer experience”.

Forward-thinking companies like Merck48, AbbVie49, Bristol-Myers Squibb50, Pfizer51, and Johnson & Johnson52 have always known the power of innovative-thinking, and such understanding will allow them to remain dominant global drug-makers with incredible therapeutic momentum. The odds are that their sales forecasts based upon investments in innovative ideas will eventually manifest as a great stock performance over the next several years.

The ultimate news for drug-development stakeholders is that the work to develop time-sensitive pathway for streamlining operations with intuitive workflows, advanced analytics, and smart devices has already begun. Bloomberg Press53 reports promising revenues for the RCT service markets, which are slated to grow 10% annually for the next 5 years and will be worth $150 billion by 2030. And this is why smart investments in solutions from companies like P360 is so important. 

To learn more about all of P360’s innovative products, visit P360.com.

[clivaldatabase]

Clival Database is a comprehensive platform designed to support Clinical Drug Trials and the Clinical Drug Development Process. From drug discovery and development to managing Clinical Trials Applications, Clival Database streamlines every stage of the clinical trial journey. Researchers and healthcare professionals can rely on Clival Database to optimize drug discovery, manage trial data, and improve efficiency throughout the Clinical Drug Development process. Trust Clival Database to advance your pharmaceutical research and innovation.

[market-insider]

Clinical Trials : Holistic Exploration of the Current State and Future Outlook

The global clinical trials market size is expected to reach USD 123.5 billion by 2030, expanding at a CAGR of 6.49 from 2024 to 2030, according to a new report by Grand View Research, Inc. An increase in the volume and complexity of clinical trials has been witnessed lately, which plays an important role in the R&D of new drugs and products. The market witnessed a decline of 6% in 2020 owing to the COVID-19 pandemic. However, the market is projected to recover from 2021 onwards. In addition, clinical trials have become increasingly costly, adding to the overall cost of developing a drug.

Clinical Trials Market Report Highlights

The phase III clinical trials segment dominated the market with a 53.3% share in 2023. This can be attributed to the complexity of this phase

The interventional studies segment dominated the market in 2023. It is one of the most prominent methods used in clinical trials in the study design segment owing to the increasing demand for the intervention for clinical trials by researchers

North America held 50.3% of the market share in 2023. Favorable government initiatives and the presence of a large number of players in the U.S. that offer advanced services are responsible for market growth

Asia Pacific region is anticipated to grow at the fastest CAGR over the forecast period owing to the increasing patient pool and cost-efficient services.

For More Details or Sample Copy please visit link @: Clinical Trials Market Report

The increasing need for developing new drugs for chronic diseases, such as cancer, respiratory disorders, diabetes, cardiovascular diseases, and others, is creating immense pressure on the healthcare industry. The COVID-19 pandemic and the increasing demand for developing a suitable treatment are driving the market. The high number of people affected by the disease further depicts an increasing need for therapeutics & vaccines. Currently, there are 288 therapeutics and 106 vaccines under development, out of which, nearly 7.0% of therapeutics are in Phase IV, 21.0% in Phase III, and 43.0% & 13.0% in Phase II & Phase I, respectively.

The pandemic has resulted in the global disruption of traditional onsite clinical trials. Hence, regulatory bodies worldwide have undertaken various initiatives for fast-tracking clinical trials for the development of innovative solutions. One such instance is Solidarity, an international clinical trial launched by the WHO to find effective treatment against COVID-19. Although the pandemic has forced many medical device & drug developers to revise the approach to such crises, integrating best practices within clinical trial procedures & adapting to virtual trials, which can support the continuous development of therapeutics.

ClinicalTrials #HealthcareResearch #MedicalInnovation #DrugDevelopment #PatientRecruitment #Biopharmaceuticals #ClinicalResearch #RegulatoryCompliance #DataManagement #PatientEngagement #PrecisionMedicine #TherapeuticTrials #CROs #ClinicalResearchOrganizations #GlobalHealth #ClinicalStudyDesign #PharmaceuticalIndustry #BiotechResearch #ClinicalEndpoints #HealthTechIntegration