Running A Better Clinical Trial
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The document provides tips for effectively designing and conducting clinical trials. It emphasizes thoroughly planning trials through intelligent design, seeking FDA guidance, maintaining control over studies while partnering with CROs, only collecting necessary data, using appropriate sample sizes, and maintaining transparency. The overall message is to plan carefully, involve the FDA, demand accountability from partners, and use technology to drive efficient processes.
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Provides an overview of the later stages of drug development, explaining the phases of drug studies and explores in brief the key roles for those participating.
How To Optimize Your EDC Solution For Risk Based Monitoring
This presentation presents best training practices to leverage EDC technology and risk-based monitoring to effectively and efficiently monitor clinical research.
Our focus is on the practical process of preparing your team to optimize the tools made available through an EDC solution.
This presentation is applicable to CRA’s, clinical project managers, clinical data managers, regulatory compliance professionals, and those involved in the design and implementation of risked-based monitoring plans.
Data and Safety Monitoring Board - An Overview
Presentation regarding history, purpose, role, functions, meeting, member responsibilities, report of a Data and Safety Monitoring Board (DSMB)
Semantic web mining for Pharmaceutical Business Intelligence
Applying semantic web mining techniques to analyze global research activity can provide valuable business intelligence. Semantic web mining uses ontologies, vocabularies, and rules to infer relationships and extract meaning from various online sources of medical and scientific information. This inferred and aggregated data can be used to profile key opinion leaders, rank organizations conducting relevant research, monitor global clinical trial activity, and help companies make better strategic decisions around areas like new trial placement. Emerging regions and therapeutic areas with increasing research activity can be identified to guide business development decisions.
Challenges and Opportunities Around Integration of Clinical Trials Data
Conducting a Clinical Trial is a complex process, consisting of activities such as protocol preparation, site selection, approval of various authorities, meticulous collection and management of data, analysis and reporting of the data collected
Each activity is benefited from the development of point applications which ease the process of data collection, reporting and decision making. The recent advancements in mobile technologies and connectivity has enabled the generation and exchange of a lot more data than previously anticipated. However, the lack of interoperability and proper planning to leverage this data, still acts as a roadblock in allowing organizations truly harness their data assets. This document will help life sciences IT professionals and decision makers understand challenges and opportunities around clinical data integration
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The high stakes of running an oncology clinical trial
Unlike other therapeutic trials, oncology trials are more sensitive in nature and require specific clinical expertise to properly manage. Many participants are required to have already undergone front and even second lines of therapy and only if these have failed are they eligible for the experimental and toxic drugs often required in oncology trials. Costs are high, enrollment can be challenging and you are often working with medically-fragile patients. However, when managed properly, effective oncology trials can save lives, generate new revenue streams and make breakthrough discoveries in a challenging therapeutic area.
Data & Technology in Clinical Trials
This document advertises and provides an agenda for the "Data Quality & Technology in Clinical Trials 2016" conference to be held in Philadelphia on April 18-19, 2016. The conference will focus on how pharmaceutical companies can maximize data quality, become data-driven organizations, and harness analytics to improve clinical trial design, monitoring, and outcomes. Speakers will include executives from major pharmaceutical companies as well as regulators and discuss topics like unlocking value from clinical trial data, using patient-generated data, and harnessing new technologies in clinical trials. The goal is to help pharmaceutical companies transition to being data-driven organizations and improve clinical development timelines and success rates through better data practices and technologies.
Healthcare quality improvement for meaningful use
The document discusses meaningful use of electronic health records and quality improvement processes for healthcare providers. Meaningful use involves using certified electronic health records to improve care quality, engage patients, improve care coordination, and maintain privacy. Providers must meet objectives across three stages related to clinical quality reporting. The quality improvement process involves defining aims, measuring baselines, analyzing processes, testing changes through PDSA cycles, and tracking results. Resources for meaningful use and quality improvement include the CMS website and regional extension centers.
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Principles of surgical audit
This document outlines the process of clinical audit, which involves comparing aspects of patient care against explicit criteria to improve outcomes. It discusses establishing structure, measuring processes, and evaluating outcomes. The document also describes the audit cycle of preparing, selecting criteria, measuring performance, making improvements, and sustaining them over time. Clinical audit is presented as a way for healthcare professionals and organizations to critically examine practices and ensure patients receive optimal care.
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This document discusses challenges in assuring pharmaceutical quality and proposes solutions. It begins with two case examples of companies reaching a "tipping point" in moving from reactive to proactive quality approaches. It then outlines how to effectively integrate process analytical technology (PAT) guidance and other quality guidelines to make continual improvement normal, easy and rewarding. Finally, it proposes understanding uncertainty and human factors when assuring quality, and providing a framework to classify gaps to address challenges. The overall message is that recognizing legacy issues and integrating quality approaches can help advance from problem-solving to error prevention.
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This document discusses challenges in using Bayesian and decision analysis approaches for regulating medical products. It notes issues like subjectivity in choosing priors, controlling type I error rates, and the need for legal availability of prior information. Promising areas for using prior information include pediatric trials, rare diseases, safety, and expedited access programs. Bayesian adaptive designs allow interim analyses to optimize sample size and model-based likelihoods. Decision analysis can make benefit-risk determinations more explicit through tools like influence diagrams and considering patient preferences. The highest value of Bayesian approaches is in accounting for external evidence, using flexible trial designs, modeling likelihoods, developing transparent decision rules based on factors like medical need and patient perspectives.Similar to Running A Better Clinical Trial (20)
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Game plan for therapeutic cancer vaccines
Pioneering novel therapeutics is always an uncertain endeavor. Thus, the story of therapeutic cancer vaccine development has been a story of challenges, but they are not insurmountable.
Just in-time-clinical-trial-monitoring
Improved technology adoption and clinical operations processes are now making it possible to redefine the role of the CRA, while at the same time reducing stress, decreasing costs and increasing clinical trial oversight. At Clinipace Worldwide, we’ve adopted a methodology called Just-in-Time Monitoring that is dramatically changing the way we interact with our trial sites.
Top 5 Warning Signs Your Clinical Trial Is Off Track
This document discusses risk management in clinical trials. It outlines a four-step process for risk management: risk assessment and analysis, risk mitigation, risk measurement, and risk management. It provides examples of early warning signs to look for during study start-up and operations, how to measure those risks, and how to address risks that become issues. Some potential risks discussed include slower than expected enrollment, poor site compliance, and breakdown of sponsor-CRO relationships.
Four Practical Approaches To Managing A More Effective Device Trial
This document discusses four practical approaches to managing effective device trials:
1) Consider the appropriate regulatory path and reimbursement strategy to maximize trial and product success.
2) Understand the patient population and customer setting to ensure the trial design reflects real-world use.
3) Incorporate complete trial visibility with technology-driven processes to efficiently manage operations.
4) Clinical trials require significant investment but technology can reduce costs while improving processes like enrollment and data management.
REMS: the long tail can sting you
The document discusses Risk Evaluation and Mitigation Strategies (REMS), which were introduced by the FDA Amendments Act of 2007. REMS allow the FDA to require risk management plans from drug manufacturers to ensure that a drug's benefits outweigh its risks. The document outlines the various elements that can be required in a REMS, including medication guides, communication plans, and elements to assure safe use like restricted distribution and registries. It also discusses factors the FDA considers in determining whether a REMS is needed and the experience with the first drugs approved with a REMS.
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In this FREE 45 minute webcast held on June 26th, 2008, we discuss the opportunities and challenges of starting and managing an investigator-initiated research program.
In addition, we shared best practices on how to ensure executive-level buy-in, alignment with research initiatives and product strategy, grant promotion and evaluation, tackling transparency in an age of increasing regulatory oversight, and selecting and implementing the right tracking and management system to ensure success.
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对于老客户或者被老客户介绍过来的朋友，我们都会适当给一些优惠。
选择实体注册公司办理，更放心，更安全！我们的承诺：可来公司面谈，可签订合同，会陪同客户一起到教育部认证窗口递交认证材料，客户在教育部官方认证查询网站查询到认证通过结果后付款，不成功不收费！
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Running A Better Clinical Trial
- 1. February 26, 2009 Ron Marks, Ph.D. Chief Scientific Officer Clinipace
- 2. Is this necessary? www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2008 (Washington, DC: PhRMA, March 2008). Regulatory Analysis Operations Design
- 3. We already know www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Thomson CenterWatch 2003, 2005 survey of sites in U.S.
- 11. Q&A www.clinipace.com © 2003-2009 Clinipace, Inc. All Rights Reserved. Ron Marks, Ph.D. [email_address]