Outsourcing in Clinical Trials 2020 A Virtual Experience

• Understanding the expectations between the trial sponsor and vendor through conducting a cross-functional risk assessment at both the programme and protocol level
• Incorporating RBM as a tool to strengthen communication with the CRO rather than a means to forego on site meetings by allowing active oversight throughout the trial
• Developing the relationships needed with the site and ensuring the site feels properly supported throughout a study to promote a positive reputation with the CRO for future trials
• Taking advantage of the increased availability of real-time data throughout the study to ensure any issues that arise can be addressed by the trial sponsor and CRO in a timely manner

Live Q&A with presenter

• Integrating the ‘Quality by Design’ model into study protocols to ensure not only good trial design but good execution
• Introducing risk as an influencer of the quality of the trial to determine the probability and impact these will have to the integrity of the study and whether these risks are acceptable or should be mitigated
• Ensuring the quality of the data is ‘fit-for-purpose’ using pre-specification to make use of existing data over primary data collection in both feasibility analysis and statistical analysis
• How the new guideline will fit in and/or effect current guidelines in place such as Good Clinical Practice (GCP) and other ICH efficacy guidelines 

Live Q&A with presenter

• Overview of need-to-know requirements and submission process updates
• Defining a framework of action including preparation timelines, in-house staffing considerations, and the contents of a dossier submission
• Outline of the most common pitfalls, the potential penalties associated with them, and how to avoid delays
• Recommendations for the evaluation and selection of the right outsourcing partner and when best to initiate

TBD, Synteract

Live Q&A with presenter

• Looking to navigate how the new MDR may be impacted by the separation of the UK from the EU
• Locating the correct notified bodies to ensure compliance with MDR regulations under an uncertain regulatory relationship between the UK and EU
• Ensuring your trial complies with the data quality updates to secure certification in future trials
• Will the UK MDR 2002 correlate with the updated EU regulations to streamline the certification of medical devices in the UK and Europe

Live Q&A with presenter

• Deciding to move a study from one vendor to another one due to either lack of performance or the inability for the CRO to effectively to conduct the trial
• Ensuring the least disruption to a study during the transition period using methods such as having the rescue CRO work alongside the original CRO
• Conducting a thorough investigation to locate the root cause of the failure to ascertain the level of intervention needed
• Ensuring the rescue CRO has documented success with rescuing other studies as well as the resources needed for a specific trial

Live Q&A with presenter

• Australia and New Zealand’s pragmatic ecosystem for early phase trials
• Accessing the Australian Government’s generous R&D tax incentives through Biotech Connect
• Why European Biotechs are heading to Asia for their clinical trials
• The advantage of running global trials with regional CRO partners

Live Q&A with presenter

• Looking at the impact the new regulations have had on the process of gaining certification of medical devices across both the UK and the EU post-Brexit
• Understanding the new requirements for clinical data required to achieve certification for medical devices which include having a clinical evidence report showing scientific validity of data based on the products intended use
• Methods for proactive post-market monitoring of medical devices for safety incidents and performance to simplify the future recertification process
• Working with notified bodies both within and outside of the UK to ensure medical devices are properly certified in the UK as well as European nations

Live Q&A with presenter

• Ensuring data quality by using AI algorithms to analyse historical operational data to ensure feasibility of the trial
• Using AI to identify the best suited patient populations for a trial using algorithms to search various databases including electronic health records, pathology reports and written doctors notes
• Using Machine Learning to support stronger RBM, predict risk and enable better resource management for faster approval times and reduced costs drug approval times and reduce overall costs of the trial
• Supporting decentralized trials through monitoring the patient for drug adherence as well as measured drug responses using telemedicine tools such as mobile phone applications

Live Q&A with presenter

TBD, AICure

• Knowing what questions need to be answered regarding the feasibility of any adaptation to the trial
• Lowering the overall cost of a clinical trial by utilising an adaptive approach to allow flexibility at any point within the study
• Examining how to implement adaptations whilst maintaining simple interpretation, reporting and analysis of results
• Strategies for patient recruitment within an adaptive trial – methods for identifying and continuous recruitment through the study life-cycle

Live Q&A with presenter

• Early strategies to ensure the CRO understands the needs of the trial sponsor by checking understanding of items such as the master protocol
• Ensuring open communication between both parties as a means to effectively nurture the trial at every stage
• Looking at various situations of conflict between CROs and Trial Sponsors and the solutions used to resolve them
• Lessons learned throughout past trials to apply towards future vendor relationships

Live Q&A with presenter

• Scrutinising the data collected and verified to limit delays during data collection and entry by ensuring the data has been 100% source verified
• Navigating updated Clinical Trial Regulation data reporting requirements post Brexit – ensuring the trial is registered in a public register either primary or partner to the World Health Organisation’s International Clinical Trial Registry Platform
• Integrating technology into your trial by utilising tools such as ePro to record real time data directly from patients
• Ensuring the boundary between those in clinical data management and clinical monitoring are not blurred due to implementation of electronic data management systems

Live Q&A with presenter

• Ensuring optimal recruitment, compliance and patient retention through patient-centric clinical trials
• Understanding the patients journey through the healthcare system
• Developing an intimate knowledge of hospital systems, processes and (above all) people
• Illustrating the benefits of a patient centric approach using case studies from Early Phase Rare Disease trials to Real World Evidence projects

Live Q&A with presenter

• Steps for using the bid defence meeting to assess whether the CRO will prioritise your small biopharma study
• Verifying what steps the CRO has in place post-Brexit to ensure they are prepared to conduct the study
• Assessing the CROs ability to meet patient enrolment deadlines based on the patient pool they have access to
• How using a smaller CRO can give a study the attention that it may lack from a larger CRO due to smaller caseloads

Live Q&A with presenter

• Enhancing the patient experience to ensure they are seen as a person rather than a number within a trial which will enhance ‘word-of-mouth’
• Integrating efficient micro sampling strategies to decrease the burden on the patient to travel to clinical sites
• Methods of ensuring the patient has ample knowledge of the outcomes of their trial and is encouraged to participate and recommend further studies
• Approaches to secure specialised groups of patients for cell therapy and rare disease trials such as virtual participation

Live Q&A with presenter