The evolving landscape of clinical research presents sponsors with challenges such as faster recruitment, better compliance, and amongst sustained patient retention.  Active patient engagement throughout the trial journey is crucial to address these challenges. Involving patients early offers valuable insights, improving protocol design and study execution.

Software is becoming increasingly common in healthcare and clinical research. Therefore, it is good to know whether you are dealing with Medical Device Software (MDSW) and with the Medical Device Regulation (MDR). Not only MDSW manufacturers are confronted with the MDR, but also the pharmaceutical and food industries, not to mention researchers and healthcare providers.

Give an overview of the regulatory landscape for paediatric research, review specifics and most important challenges with corresponding solutions in paediatric drug development and review specifics and most important challenges with corresponding solutions in paediatric drug development.

Following the training, the participants will be familiar with the ethical and regulatory issues, specific protocol considerations and age groups, Informed Consent and Assent processes, drug formulations, safety specificities, recruitment, enrolment, and clinical monitoring specificities, as well as site interactions, relationships with paediatric research networks and infrastructures. Participants will be prepared to plan and execute paediatric clinical trials in any of the age groups which will result in obtaining higher quality data.

Monitoring is a key component in clinical trials. ICH GCP R(2) defines the purpose of monitoring to verify that: a) The rights and well-being of human subjects are protected. b) The reported trial data are accurate, complete, and verifiable from source documents. c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s). 

The archiving of clinical trial records is a required process that is in need of future direction to meet current business models as well as regulatory and legal expectations.  A group of industry experts coalesced under EUCROF and the eClinical Forum to formulate a position paper discussing the needs and proposed practical directions for archiving of clinical research. The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities.

Platforms have habitually disrupted unregulated industries, such as retail and tourism, but are now moving to more regulated sectors, such as finance and mobility. Healthcare is next; Digital-Health-Platforms (DHPs) are rising and will transform the way care is delivered across all dimensions (the Where, the Who, the When, and the How). 

These Digital Health Platforms are also a strategic enabler for Medical and R&D: Sanofi inked a big deal with A.I. discovery company Exscientia and AstraZeneca took stake in Huma to make clinical trials more efficient with digital technology. 

However, there is still a long way to go.

A person centric approach is a new developing concept in Clinical Trials where all the different participating groups perspectives are considered in order to improve efficiency and overall experience.

With the EU Clinical Trial Regulation becoming effective on 31 January 2022, a new era of clinical trials with medicinal products has begun in the EU/EEA. The EU legislator provided for a 3-year transition period in which the former system under the EU Clinical Trials Directive and the new system under the EU Clinical Trial Regulation are available in parallel.  Sponsors need to know how to best use this period for ongoing clinical trials, but maybe also for trials that are soon to be submitted. Strategic decisions will be necessary and the switch from one legal framework to the other must be well understood. 

The archiving of clinical trial records is a required process that is in need of future direction to meet current business models as well as regulatory and legal expectations.  A group of industry experts coalesced under EUCROF and the eClinical Forum to formulate a position paper discussing the needs and proposed practical directions for archiving of clinical research. The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities.

Clinical trials are research studies that use a group of participants to test health-related treatments or interventions. Historically, those studies have occurred mostly in centralized settings. This means that clinical trial visits involved the participant going to where the study principal investigators were practicing their regular duties, i.e. in clinics, hospitals or physician offices.

…not anymore about whether it is possible, but about how soon it will be achieved.

The GDPR (General Data Protection Regulation) has been with us for three years now. Yet, the industry continues to struggle through the multiple legal interpretations of how the GDPR requirements apply to the clinical research.
Ethics committees, data protection officers of the clinical sites and of study funding sponsors, as well as the other stakeholders, defend their approaches. This altogether expands the gap in how a CRO and therefore, a Sponsor should process personal data to state with confidence, “We are GDPR compliant”.

As of January 2022, only 9 months from now, all scientific research with medicinal products in the EU need to be submitted via the Clinical Trial Information System, the CTIS. To make sure all future users of the CTIS system, both sponsors and member states, are familiar with the settings and way-of-working in the system, the EMA has setup a training program.

This webinar on electronic informed consent (eConsent) addresses the practical considerations when implementing eConsent. It introduces the EUCROF Implementation Practical Guide to eConsent which addresses key themes and hot topics, and provides a view on the modernization of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic.

The presentation covers epidemiology, infectivity and incubation period, mode of transmission, clinical presentation, prevention, socio-ecological impact, frequently asked questions, and clinical trials with COVID-19 together with the risk management.
The treatment was intentionally not covered.

Hospitals are over-burdened and people have to stay home as much as possible. How are we dealing with study visits and other aspects of the trials? This webinar sheds light on a risk-based approach to ongoing trials and the international guidance that has been released, to protect trial subjects as much as possible and limit the damage to ongoing trials as much as possible. The webinar highlights the situation for the sites as well as for the sponsor/CROs, goes into dealing with quality control, and looks to find opportunities that may come from this difficult time.

Patient centricity has become something of a buzz phrase over the last few years. However, behind the name lies a concept that offers real value. During this webinar, these benefits will be discussed, highlighting:

1. Results from recent research that quantifies the positive business impact to sponsors by taking a patient centric approach 
2. Exploration of real examples where the patient has benefited from being put at the heart of clinical research
3. Advantages experienced by sites when patients are central to study planning and implementation

This informative session will arm you with data and examples to take to your own organization to support the build and growth of patient centric practices. In addition, a collaborative discussion about the future of patient centricity and its effect on the industry will complete the webinar.

Moreover, the webinar will provide practical examples on how to involve children in clinical trials. 

Towards a EUCROF Code of Conduct for Data Protection.

Nowadays, the collection, analysis and processing of data originated from a clinical study or for marketing settings is supported by specialized applications. Therefore, validation of computerized systems has become a central aspect in CRO’s daily work.

This webinar aims to give a general overview of validation procedures focusing on validation processes of non-configured (GAMP category 3) and configured (GAMP category 4) products. To illustrate this, we will play through the validation steps with the help of an example. Furthermore, we will present relevant guidelines and typical roles and responsibilities in validation and we will look at what we have learned so far from audits and inspections.

With the increasing complexity of the clinical trials, a need has surfaced for emphasising critical vs less important aspects of clinical trial management. Analysis for the efficacy of the traditional approach to monitoring of clinical trials demonstrated an unfavourable ratio between efforts and effect. ICH GCP E6 R2 defines innovative approaches, which include Quality Risk Management, Quality-By-Design, prioritised resourcing and risk-based monitoring. This webinar will focus on risk-based monitoring as a principal measure for improving the quality and effect of the outcome of the clinical trials monitoring, whilst respecting resourcing needs. Other main topics will include remote and centralized monitoring and their role in the risk-based approach.