NEW Date: Tuesday, March 14, 2023

This webinar will be run in collaboration with the Society for Clinical Research Sites (SCRS) and attendance is free for members of the SCRS.

Learn how your site can speed up eligibility screening and patient recruitment into trials.

Note: the date has been updated to March 14, 2023!

Full webinar details >

Date: Thursday, December 8, 2022
Time: 11 am ET

Real World Data, like the patients from whom they are derived, come in all colours, shapes, and sizes. Real World Data can be EMR data from hospitals, claims data from pharmacies, patient registry data, patient reported outcomes as well as EDC / eCRF derived data from patients’ chart reviews. Each of these sources have explicit advantages and use, case-specific to the type and extent of data collected.

Increasingly, the critical need in evaluating RWD sources is to understand the intent and analytical goal or research question to determine whether the data have the scope and metrics needed to be effective. Data, just like an input into any effort or process, must be fit for intended purpose, and if not, may be more ineffective than good.

The discussion will highlight the variety of RWD sources, their advantages and disadvantages as well as how different sources can be combined to create a greater value than the parts alone.

Meet our speakers:

• Douglas Drake, MS, MBA, Senior Director, Client Solutions, Clinerion, is originally a life science researcher with a passion for digital enablement of better patient care. For over 30 years, Douglas has worked in various aspects of diagnostics, therapeutic research, drug discovery and global business development. He has broad experience in transformative technologies, data sciences, digital healthcare and applying these to improving patient engagement and the patient journey.
   
• Rob Staszewski, M.A., Sr. Manager, Clinical Systems & Informatics, United Therapeutics Corporation, has 17 years of industry experience working on clinical trials, both from the CRO and Sponsor perspective. Originally, Rob started as a CRA at a small CRO for three years, then moved to United Therapeutics (UT), a Biotech company, where he has been for the past 14 years. At United Therapeutics, Rob has held various roles as a CRA, a Clinical Trial Manager, and a Clinical Oversight Lead. For the past five years, Rob has been managing the CTMS. Rob was also selected as part of the team that uses Remarque QRMS at United Therapeutics.
   

Register for the webinar >

Date: Tuesday, October 19, 2022
Time: 10 am ET

Digital technology is enabling not only more digital engagement but also results in more digital healthcare data being generated than ever before. As a result, digital patient records are now a major source for the collection of real-world data (RWD). When used effectively, RWD can be turned into real-world evidence (RWE) and be transformative in generating evidence that supports drug efficacy and commercial healthcare application. However, the real-world data collected needs to be appropriate for use, fit for purpose, and effective in addressing the question or research topic.

In this webinar, we will present some examples in working with RWD extracted from electronic health record (EHR) systems and how this compares to data that tends to be generated in randomized clinical trials (RCTs) which, today, are still the gold standard in clinical evidence generation. We will be touching on some of the key differences between RCT endpoints and the healthcare data recorded in the clinic that tends to drive clinical decision making, and how this affects our ability to compare RCT results with RWD for RWE generation. And we will explore some of the growing benefits and opportunities that EHR data presents in making clinical research more effective and efficient. We will also present how Meta-analysis can allow us to compare several interventions simultaneously by analyzing studies making different comparisons in a single analysis.

Speakers:

• Ahmed El Rhali, President & CEO, Datametrix
• Douglas Drake, Senior Director, Client Solutions, Clinerion
   

Register for the webinar >

Date: 12 July, 2022

Health systems of all sizes across the world can contribute to real-world evidence (RWE) and share in the learnings to improve healthcare delivery.

Regulatory bodies around the world are increasingly accepting RWE in addition to clinical trial data for new drug applications and post-marketing surveillance, and pharmaceutical companies are increasingly looking for global clinical datasets representing diverse populations that can help them understand the safety and effectiveness of therapies by patient sub-segments.

This webinar explains how your healthcare institution can participate in this new era of evidence generation:

• The latest trends in RWE generation and the role of regulatory bodies and pharma companies
• How health systems are participating in RWE, including examples
• Benefits to health systems and other stakeholders
   

Clinerion was pleased to present this webinar in collabration with the Evidence Base. The speaker was Akshay Dhawan, Senior Director, Real-world Data, Citeline (formerly Pharma Intelligence), who is leading the development of one of the largest global datasets on the market, with over 400 million lives of data, with the aim of improving healthcare operations and delivery worldwide.

Watch the webinar recording >

Date: May 11, 2022

Clinerion's Customer Solutions Director, Daniel Gutierrez, PhD, spoke at a Healtheconomics.com webinar on "Data Integrity in Decentralized Clinical Trials (DCTs)", sponsored by Actu-Real. Watch the recording to learn how Clinerion's Patient Network Explorer platform can boost data integrity!

The expert speakers expanded on the need for a comprehensive understanding of all sources of data in DCTs, and the need to evaluate those data centrally in real time to mitigate the risks associated with their capture (including data capture at the edge of the network (wearables)).

Every disruptive innovation must be complemented by adapted procedures, and this also applies to decentralized clinical trials (DCTs). Traditionally, sites entered clinical trial data in an Electronic Data Capture (EDC) system and these source data were verified at the site to confirm accuracy. Risk based monitoring focused on site level metrics such as screen failure rates, query rates, Serious Adverse Events (SAEs) reported, missed/late visits, etc. With DCTs, as source data are collected directly from participants this is no longer an option and a different approach is required to ensure the quality and integrity of the data. As a rule, a comprehensive understanding of all sources for data capture in a clinical trial and the process for centralization is essential. Also, it is important to evaluate the data collected in real time to allow early interventions that will ensure data integrity for regulatory submission.

Access webinar recording >

Date: Wednesday, January 11, 2022

This webinar focused on Data Interoperability in the context of Life Sciences. Our distinguished speaker, Nikhil Kumar, the President & Founder of Applied Technology Solutions, Inc., discussed:

• Business opportunities and implications of a data-enabled Pharma enterprise - leveraging RWE 
• The current landscape and FDA specs
• Data Interoperability - the future state pharma landscape and new additions to the FDA landscape and standards
• Data Interoperability and trends and their impact - a quick review of Data Mesh/ Data Fabric and practical implications to the life sciences/pharma enterprise
• Architectural implications of data interoperability 
• Security and Zero Trust and its implications for the Digital Pharma Enterprise
   

View the webinar recording >

Date: Tuesday, November 9, 2021
Time: 4 pm CET

Digital technology is enabling not only more digital engagement but also results in more digital healthcare data being generated than ever before. As a result, digital patient records are now a major source for the collection of real-world data (RWD). When used effectively, RWD can be turned into real-world evidence (RWE) and be transformative in generating evidence that supports drug efficacy and commercial healthcare application. However, the real-world data collected needs to be appropriate for use, fit for purpose, and effective in addressing the question or research topic.

In this webinar, the panel discussed their experience in working with RWD extracted from electronic health record (EHR) systems and how this compares to data that tends to be generated in randomized clinical trials (RCTs) which, today, are still the gold standard in clinical evidence generation. They touched on some of the key differences between RCT endpoints and the healthcare data recorded in the clinic that tends to drive clinical decision making, and how this affects our ability to compare RCT results with RWD for RWE generation. And they explored some of the growing benefits and opportunities that EHR data presents in making clinical research more effective and efficient.

Access webinar details and recording >

Date: Saturday, October 30, 2021
Time: 7 pm CET | 8pm AST

PLEASE NOTE THIS WEBINAR HAS A NEW DATE.

This webinar will be run in collaboration with RAY Contract Research Organization.

Full webinar details >

Date: Thursday, October 28, 2021
Time: 1.15 pm EST | 7.15 pm CET

Clinerion-led panel, part of the DIA's Digital Technology in Clinical Trials virtual event (Session 7 Track B at), October 27-29, 2021.

Can we leverage more real-world data (RWD), from electronic health records (EHRs) to create deeper information and insights into patient care regimens, journeys and outcomes? As RWD moves "up the R&D value chain" and into pipeline prioritization and into early research, development, clinical research, patient journey (insights) and regulatory applications, we investigate what constitutes "fit for purpose" RWD.

Full webinar details >

Date: Wednesday, October 27, 2021
Time: 7 am PT | 10 am ET | 4 pm CET

This webinar was run in collaboration with the Critical Path Institute.

The Rare Disease Cures Accelerator–Data and Analytics Platform is launching a new webinar series with the goal of sharing with the community examples of the use of rare disease person-level data in drug development and regulatory decision making. The series will feature 1-hour webinars highlighting analyses that have been done in individual disease areas, how they informed drug development, and how similar approaches could be applied to common drug development issues encountered in rare diseases. After each presentation time will be allowed for discussion with a panel of Quantitative and Regulatory experts around why the solutions presented were informative, lessons learned and how similar approaches could be applied to related problems.

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Date: Wednesday, October 27, 2021
Time: 7 am PT | 10 am ET | 4 pm CET

Clinerion CEO Baris Erdogan chaired this webinar run by the Galien Foundation.

Will the success of novel, gene-based therapies in advancing survival timelines in blood and bone marrow cancers be repeated in the solid tumor setting, with therapies that address each tumor’s individual genetic profile rather than association with its geographic location in the body?

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Date: Wednesday, October 20, 2021

As the volume of both clinical trial and real-world data continues to grow exponentially, the pharma industry is struggling with data interoperability issues and gaining actionable insights. There is a critical need to address concerns around data standardization, security, ownership, and building robust data governance models to enable data integration. And what does it mean to integrate our data in the first place?

The DIA Data Interoperability Working Group roundtable (incl. Clinerion's Douglas Drake) explored these topics as well as evolving models such as data fabrics, federated learning platforms, and digital ecosystems.

View the webinar recording >

Date: Tuesday, October 5, 2021

This webinar was run in collaboration with the Society for Clinical Research Sites (SCRS) and attendance is free for members of the SCRS.

Scientific development has always been founded on the latest technology. Today, this means the explosion of digitalization of medical information. When it comes to drug development, the hurdle is access to the right patients, whether it be finding enough patients of different ethnicities, or finding enough patients with a specific confluence of phenotypic markers fitting a clinical trial protocol.

Today, the digitalization of medical records has unleashed the possibility of searching for patients across institutions, enabling trial researchers to work with patients on a global scale. Trial protocols can be tested and modified against live patient data, sites with large clusters of eligible patients can be identified, patients can be reidentified for trial recruitment at any site. In this webinar, we will outline the current trends, and offer real-world case studies.

Full webinar details >

Date: Tuesday, September 21, 2021

As rare diseases are so rare, patients are often misdiagnosed for many years, or never correctly diagnosed. Electronic health records hold much important information that can be used to correctly diagnose and treat these patients, but identification of phenotypic sets is hard to extract from reams of data.

In this webinar, along with speakers from Volv Global, Sanofi, and the Svabhegy Paediatric Hospital, Hungary, we assess the issues facing patients of rare and orphan diseases. We look at current developments in large hospital patient data networks, which enable automated patient search while keeping the identifiable patient data within the hospital systems, as well as the growing sophistication of artificial intelligence/machine learning models which can learn to identify sets of phenotypes for hard-to-diagnose diseases.

Access webinar details and recording >

A live fireside chat with Clinerion CEO Barış Erdoğan by Natalie Yeadon, Impetus Digital

Date: Wednesday, September 1st, 2021

Barış Erdoğan, CEO of Clinerion, sat down with Natalie Yeadon to explore how medical data informatics and real-world EHR data can be used to improve the efficiency and effectiveness of patient searches, identification, and recruitment; clinical trials; and drug development to ensure earlier availability of medicines.

Full details, incl. a recording of the livestream >

Date: Monday, May 24th, 2021

Clinerion will be the focus of a case study for students from the IMD business school, Lausanne, Switzerland.

We have a winner!

Full details of the competition >

Continuing our support of clinical research in Brazil, we are pleased to present a webinar by Roberta de Almeida, Teaching & Research Coordinator at a key Brazilian hospital in our global site network, Santa Casa de Porto Alegre, together with our partner, iHealth.​

Date: Thursday, March 11-Friday, March 12, 2021
Language: Portuguese

Management and Operation in Clinical Research (in Portuguese: Curso de Gestão e Operacão em Pesquisa Clínica) was taught by Roberta de Almeida (Teaching and Research Coordinator at Santa Casa de Porto Alegre), offering a certificate upon completion.

The webinar was broadcast on YouTube by Martagão Gesteira.

Webinar recording >

Date: Tuesday, November 17, 2020
The webinar recording is now available!

The real-world data is there. How do we leverage it to produce actionable real-world evidence? Leading experts from Turkey discuss their experiences working with real-world data, including successes from use of healthcare data from Clinerion's Community of healthcare organizations on Patient Network Explorer.

Full webinar details >

Date: Wednesday, November 11, 2020
The webinar recording is now available!

This webinar presented a roundtable discussion by combining the experience of sponsors and CROs as well as the resources and tools of Trialbee and Clinerion to expound on a use case that that optimizes the clinical trials process in a practical and predictable way. The audience learned how to:

• Apply large global research networks to:
  • Conduct study & patient feasibility
  • Identify and select Principle Investigators (PIs) with documented access to patients
• Utilize a wide range of Real-World Data (RWD) including Electronic Health Records (EHR) and claims data to facilitate patient recruitment & engagement with automated and efficient pre-qualification of eligible patients.
• Apply multi-sourcing of patients to connect, qualify and refer “study ready” patients to participating investigator sites globally.
• Apply and analyze clinical trial process simulation to identify and mitigate risks.
• Apply operational excellence practices to take advantage of the tied resources and manage trials effectively.
  ​

Full webinar details >

Date: June 24th

We discussed how predictive analytical models are benefiting from recent advances in real world data access.

We covered the infrastructure that enables this, touch on advances like the transfer of data from EHR to EDC, and other virtual trial elements. And in doing so, explained how predictive analytics, fuelled by real world data, are ever more important and useful in clinical research as well as in clinical decision making, and drive better outcomes for patients.

Speakers and presentations:

• Irina El Ali, Chief Operating Officer, Datametrix: Predictive Analytics, what is it? Some models explained, and their utility for HC provider and HC system.
• Leon Van Wouwe, Site and Patient Networks Director, Clinerion: RWD, How to access and leverage the data. Challenges and advances.
• Dr. Faizal Rayan, Trauma & Orthopaedic Surgeon, NHS, Kettering General Hospital: A clinician’s perspective on the use and usability of Predictive Analytics and RWD to improve outcomes in clinical practice.
   

Watch recording >

Date: May 20th

We discussed how a research network/ecosystem enables researchers and clinicians to access larger pools of patients, experts in a variety of fields, and facilities offering other treatment methodologies.

Our impressive line-up of guest experts:

• Dr Katrin Crameri, MPH  - Director, Personalized Health Informatics, Swiss Institute for Bioinformatics (SIB)
• Sebastian von Lovenberg, Dipl. Ges. Ök. - Head of Sales DACH, Allm EMEA GmbH
• Sébastien Wischlen - Customer Solutions Director, Clinerion Ltd
• Prof. Dr. med. Reto Stocker – Principal, Institute for Anaesthesiology and Intensive Care Medicine Hirsdlanden, Zürich
   

Watch recording >

Date: December 17, 2019

80% of clinical trials are delayed.

Because it can take a long time to find and enrol patients for clinical studies.

In this 60-minute webinar, we discussed how Real World Data solutions and technologies will impact patient recruitment and are already acting as game changers which accelerate clinical trials.

Our expert speakers :

• Keyla Deucher, founder of Bioserv SMO.
• Ian Rentsch, CEO of Clinerion.
   

Watch recording >

Webinar: KLİNİK ARAŞTIRMALARDA ARAŞTIRICI ÖDEMELERİ VE AR-GE KANUNUNUN SAĞLADIĞI OLANAKLAR​

Date: 21 February 2018
Time: 14:00-15:00
Webinar Speakers: Prof. Dr. Yağız ÜRESİN, Mr. Ersen GÖKSER, Prof. Dr. Meral BEKSAÇ, Dr. Ergun KONAKÇI
Webinar Moderator: Dr. Barış ERDOĞAN, Head of EEMEA Region & Country Manager Turkey

REGISTRATION IS CLOSED

Description:

Clinerion creates a platform with Turkey's leading hospitals to share their experiences to bring the most frequent topic in Clinical Trials up to discussion.

Webinar attendees will be able to hear about the investigator payments and the opportunities coming with the R&D law from the leading names together with the first implementation experience.

During the webinar, all conversations will be recorded by the moderator and this record will be sent to all participants as a detailed report. Please do not forget to type in your valid email address.

You will be able to write down your questions between 14:45-15:00 in the conversation box.

This webinar addresses the following roles:

• Researcher
• CEO / Hospital Manager
• Head of Clinical Trial Unit
• Pharmaceutical companies and CROs

We are looking forward to meeting you at the webinar!
The Clinerion Team

REGISTRATION IS CLOSED

Date: October 10, 2017.
Presenter: Tigran Arzumanov, Clinerion Head of Sales.
Attendance: free.

View the webinar recording on our videos page >  

Description:
Privacy in the storage and use of personal electronic health data is understandably a major topic of concern for patients. This is reflected, e.g., in the EU General Data Protection Regulation (GDPR) coming into effect in 2018.

For clinical trial patient recruitment, current state-of-the-art uses pseudonymized electronic medical records to find eligible candidates. This technology, however, still operates with identifiable data, which has both legal and data security implications. This limits access to patient data and, as a result, limits the access patients have to clinical trials via online patient recruitment.

Clinerion has recently filed a new patent for technology which enables patient search and re-identification (by authorized trial personnel) using only anonymized patient data, ensuring the privacy and security of patient information and removing regulatory compliance hurdles in EHR-based clinical trial patient recruitment.

How does this work?

Clinerion will present our “Anonymized Identification” (ANID) technology in a free webinar on October 10, 2017. Join us, to hear all about our unique and ground-breaking new technology! The webinar will also include a basic introduction to real-time EHR-based patient search and identification for clinical trials – and there will be opportunities for Q&A.
 

Webinar Information

Date: October 10, 2017.
Presenter: Tigran Arzumanov, Clinerion Head of Sales.
Attendance: free.

There will be three webinar sessions, each presenting the same material to allow participants from all time zones to attend. Each session will last 30 minutes. Pick the session that suits you best:

View the webinar recording on our videos page >​  

These webinars address the following roles:

• Hospital President / CEO
• Hospital Superintendent / Hospital Manager / General Manager
• CIO / Chief Information Officer
• Data Officer / Data Privacy Officer / Privacy Officer
• Head of Clinical Trial Unit
• Hospital Head of IT
   

View the webinar recording on our videos page >​  

Date: January 19, 2017.
Time: 12:00 PM - 1:30 PM Eastern.

Webinar instructors: Randy Ramin-Wright, Head of Quality Risk Management and Klaudia Keller, Senior Quality Risk Analyst.

Registration: www.barnettinternational.com/Web-Seminars/Quality-Risk-Management-in-Clinical-Trials-and-Pharmacovigilance/

Description: The ICH Q9 Quality Risk Management (QRM) guideline has become an accepted standard, facilitating the development and implementation of a systematic risk-based approach to quality management of clinical trials and pharmacovigilance. Industry and regulatory bodies, including the EMA and FDA, have recognized the need and benefits of implementing a risk-based approach to quality management.

This web seminar is designed to provide a strong conceptual foundation of the principles of quality risk management with a clear focus on the application of these principles. We will address applying QRM to support decision-making throughout the clinical trial management and pharmacovigilance process, allocating limited resources effectively to areas of high risk, and preparing the participant to become an active contributor towards risk-based quality management at his/her organization.

Learning objectives:

• Define Quality Management System (QMS) levels for applicable areas in clinical trials and pharmacovigilance.
• Build quality at key points in the process.
• Apply QRM principles: Identification and quantification of key risk indicators.
• Implement a quality by design approach to overcome shortcomings in quality and compliance.
• Leverage existing information to support decision-making in resource allocation within clinical trials.
• Create a governance model to support mitigation strategies and the overall QMS infrastructure.

Date: September 21, 2016.

Webinar instructor: Randy Ramin-Wright, Clinerion Account Manager.

Registration: now closed.

Description:
Are you conducting clinical trials?
Do you want to attract international clinical trial sponsors?
Do you want to increase trial revenue and efficiency?

One of the biggest challenges in clinical research is identifying patients whose profiles match study protocols. Clinerion’s Patient Recruitment System is free for hospitals and supports patient search by querying hospital medical records. Our partner hospitals have higher visibility to international trial sponsors. At the same time, the amount of effort required to identify suitable patients is greatly reduced.

In the webinar we will demonstrate our easy-to-use Patient Recruitment System, highlighting how we make the clinical trials process at hospitals and pharmaceutical companies quicker and more efficient.

During the webinar, we will address frequently asked questions, such as those regarding patient privacy and data security. You will be able to add comments or ask questions.

This webinar addresses the following roles:

• President / CEO / Superintendent / Hospital Manager
• Head of Clinical Trial Unit
• Chief Information Officer / IT Director
• Commercial / Business Development Director
• Executives responsible for clinical trials at pharmaceutical companies and CROs
   

We are looking forward to meeting you at the webinar!
The Clinerion Team

Date: September 20, 2016.

Webinar instructor: Dr. Tigran Arzumanov, Clinerion Head of Sales.

Registration: now closed.

Description:
Are you conducting clinical trials?
Do you want to attract international clinical trial sponsors?
Do you want to increase trial revenue and efficiency?

One of the biggest challenges in clinical research is identifying patients whose profiles match study protocols. Clinerion’s Patient Recruitment System is free for hospitals and supports patient search by querying hospital medical records. Our partner hospitals have higher visibility to international trial sponsors. At the same time, the amount of effort required to identify suitable patients is greatly reduced.

In the webinar we will demonstrate our easy-to-use Patient Recruitment System, highlighting how we make the clinical trials process at hospitals and pharmaceutical companies quicker and more efficient.

During the webinar, we will address frequently asked questions, such as those regarding patient privacy and data security. You will be able to add comments or ask questions.

This webinar addresses the following roles:

• President / CEO / Superintendent / Hospital Manager
• Head of Clinical Trial Unit
• Chief Information Officer / IT Director
• Commercial / Business Development Director
• Executives responsible for clinical trials at pharmaceutical companies and CROs
   

We are looking forward to meeting you at the webinar!
The Clinerion Team

Date: September 6, 2016.

Webinar instructor: Dr. Tigran Arzumanov, Clinerion Head of Sales.

Registration: now closed.

Description:
Are you conducting clinical trials?
Do you want to attract international clinical trial sponsors?
Do you want to increase trial revenue and efficiency?

One of the biggest challenges in clinical research is identifying patients whose profiles match study protocols. Clinerion’s Patient Recruitment System is free for hospitals and supports patient search by querying hospital medical records. Our partner hospitals have higher visibility to international trial sponsors. At the same time, the amount of effort required to identify suitable patients is greatly reduced.

In the webinar we will demonstrate our easy-to-use Patient Recruitment System, highlighting how we make the clinical trials process at hospitals and pharmaceutical companies quicker and more efficient.

During the webinar, we will address frequently asked questions, such as those regarding patient privacy and data security. You will be able to add comments or ask questions.

This webinar addresses the following roles:

• President / CEO / Superintendent / Hospital Manager
• Head of Clinical Trial Unit
• Chief Information Officer / IT Director
• Commercial / Business Development Director
• Executives responsible for clinical trials at pharmaceutical companies and CROs
   

We are looking forward to meeting you at the webinar!
The Clinerion Team

Date: May 24, 2016.
Webinar instructor: Randy Ramin-Wright, Head of Quality Risk Management

Description: Could the non-recruiting site be a thing of the past? We hope so! Join us for this webinar to explore ways of using Big Data to find your perfect patient and help solve the challenge of recruiting anonymous patients. Faster and more efficient recruitment mechanisms can lead to significantly more patients being enrolled. Experience how new patient recruitment technology can potentially identify 10 to 30 times more ‘real world’ patients than those found through manual screening in a matter of minutes instead of weeks or months. Let your data speak for itself and start attracting more studies today!

Learning Objectives:

• Understand ways in which technology can help identify suitable clinical study candidates for given protocols faster and more efficiently, ultimately leading to more patients enrolled.
• Appreciate why your site is more likely to be selected for a clinical trial.
• Recognize how the operational efficiencies of your site can increase.
• Consider why connecting your site to a clinical research site network opens up new opportunities and can lead to a wider range of clinical trials bringing innovative drugs to your patient community.

Date: April 7, 2016.
Webinar instructors: Randy Ramin-Wright, Head of Quality Risk Management and Klaudia Keller, Senior Quality Risk Analyst

Description: The ICH Q9 Quality Risk Management (QRM) guideline has become an accepted standard, facilitating the development and implementation of a systematic risk-based approach to quality management of clinical trials and pharmacovigilance. Industry and regulatory bodies, including the EMA and FDA, have recognized the need and benefits of implementing a risk-based approach to quality management.

This web seminar is designed to provide a strong conceptual foundation of the principles of quality risk management with a clear focus on the application of these principles. We will address applying QRM to support decision-making throughout the clinical trial management and pharmacovigilance process, allocating limited resources effectively to areas of high risk, and preparing the participant to become an active contributor towards risk-based quality management at his/her organization.

Learning objectives:

• Define Quality Management System (QMS) levels for applicable areas in clinical trials and pharmacovigilance
• Build quality at key points in the process
• Apply QRM principles: Identification and quantification of key risk indicators
• Implement a quality by design approach to overcome shortcomings in quality and compliance
• Leverage existing information to support decision-making in resource allocation within clinical trials
• Create a governance model to support mitigation strategies and the overall QMS infrastructure
   

Who should attend:

• Clinical Research, Operations, and Development Professionals
• Medical Affairs Personnel
• Safety and Risk Management/Operations Personnel
• Compliance, Regulatory Affairs, and Clinical Quality Assurance Personnel

Date: January 27, 2016.
Webinar presenter: Randy Ramin-Wright, Head of Quality Risk Management

Description: We at Clinerion offer a cloud-based industry-hardened Quality Risk Management System that empowers both big and small clinical research organizations to execute Risk-based Study Oversight and Risk-based Monitoring.

We have released a brand new version of our Quality Risk Management System including a modern, user friendly interface providing enhanced risk data analytics.

Watch for yourself and see how you can use Clinerion's Risk Based Monitoring Application to identify and mitigate your clinical quality risks and thereby make risk based monitoring a reality at your organization!

If you did not have the opportunity to hear the webinar live, then feel free to download the presentation slides and watch the video recording of the webinar.

If you have further questions regarding the webinar topic, or if you are interested in piloting the Risk Based Study Oversight and Monitoring approach and technology, please contact our speaker:

Randy Ramin-Wright: Randy Ramin-Wright

Download Webinar Presentation Slides: Webinar RBM Demo PDF.
Watch Webinar Video Recording: 

Date: October 20, 2015.

The ICH has decided to modernize its approach to GCP in order to keep pace with the scale and complexity of clinical trials and to ensure appropriate use of technology.

In this webinar Peter Schiemann previewed what modern GCP will contain and underscored its likely impact on the organization, gave advice on how to prepare for its arrival and Randy Ramin-Wright explained and demonstrated how Clinerion's risk-based study oversight technology, the Quality Risk Radar fulfills the demands of modern GCP which includes Risk Based Monitoring.

If you did not have the opportunity to hear the webinar live, then feel free to download the presentation slides and watch the video recording of the webinar.

If you have further questions regarding the webinar topic, or if you are interested in piloting the Risk Based Study Oversight and Monitoring approach and technology, please contact our Speakers:

Dr. Peter Schiemann: Dr. Peter Schiemann.
Randy Ramin-Wright: Randy Ramin-Wright.

Download Webinar Presentation Slides: ICH GCP Addendum PDF.
Watch Webinar Video Recording: