Outsourcing in Clinical Trials Nordics 2019

Join the discussion as 3 leaders discuss outsourcing models, the benefits of local networks and how to find the right balance between functional and full service outsourcing.

• Determining the right outsourcing model for your trial: comparing local Vs global vendors and how to find the right fit
• Functional Vs full service outsourcing: identifying the right approach for each study
• Exploring different frameworks that can be employed when communicating cross-culturally to enhance understanding in a continuous and time-efficient manner
• Tips and trends for running trials in different regions and working under multiple regulatory environments simultaneously

• While the use of electronic clinical outcome assessments (eCOA) has moved from an unproven technology to the gold standard approach for capturing patient data in pivotal studies over the two decades of eCOA development, there are consistent pain points which remain to the smooth delivery of eCOA in clinical trials.
• These pain points fall into three main categories:
  • long setup timelines, typically driven by the need to implement multiple language versions of questionnaires in global studies
  • dealing with data clarifications, driven by the merging of eCOA datasets and the study EDC
  • site and patient recruitment and retention, resulting in sites not meeting recruitment targets and patients dropping out
• Medidata is addressing all of these challenges through a platform based eCOA solution which leverages technology to simplify the process of building and delivering eCOA studies. There are three key innovations underlying this platform solution:
  • a Global eCOA Library containing prebuilt, pre-approved electronic implementations of questionnaires, plus translations, which can be rapidly implemented into a study
  • a fully integrated eCOA solution, so that data flows directly from patients entry on a device to the final study EDC, removing the main source of data clarifications and cleaning efforts
  • the ability to “virtualise” appropriate aspects of a trial to be conducted outside of a site, whether it be consenting, data capture or lab tests, to design trials to be more patient-friendly.
• This presentation will discuss the current landscape of eCOA in clinical trials and share insights into Medidata’s platform-driven solution

• Manage cost and time efficiently by adopting a site-less approach through remote consent and screening to reduce time burden on patients
• Increase diversity through accessing a wider population – including difficult to recruit patients from their preferred location
• Increase opportunities to seamlessly capture real-world data through virtual clinical trials
• Lower patient burden through a direct-to-patient approach: Improve patient retention by working around the patient’s life, location and responsibilities

• Underlining the steps to align timelines and priorities between pharma and vendors
• Highlighting the role of communication and collaboration during the planning phase to ensure proposed timelines and resources are realistic
• How can breaking down silos enable creative problem-solving in the event of unforeseen challenges
• Defining a communication framework which enables both pharma and vendors to effectively report on milestones reached or missed, change trial parameters and raise issues

A win-win formula for success

• Overview of study
• Successful enrolment: meet sponsor objectives
• Quality management
• Sponsor and CRO impact in ALS community

Every patient counts

• Engage the sites (sponsor visits, close to field, advocacy groups, study portal)
• Support the patients (advocacy groups, study portal, home nursing)

Doing it together

• Not a ‘quiet river’ : joint team overcoming hurdles
• Case study : rapid Amendment implementation
• Alliance : Sponsor ALS community engagement/CRO driving operations
• Flexibility and reliability in supporting emerging needs : ad hoc Scientific and medical support, operational functional support

• Developing a robust clinical trial oversight structure for successful vendor oversight – securing the information you need, when you need it
• Designing contracts for risk minimisation and quality control – steps for making contracts work for both parties
• What happens if it all goes wrong? Building resilience in your oversight model by preparing a recovery plan when things go wrong
• Developing long-term relationships through oversight – how can contracts with clear expectations strengthen relationships

The exhibition will feature a varied line-up of innovative technologies to support the Nordic life sciences sector.

No matter your job function you’ll find providers to meet your needs; we’ll be showcasing new solutions for trial operations, supply and beyond to give you a comprehensive suite of solutions to maximise trial success.

• Identify how to select and engage with trial sites using your study parameters
• Establish the best practice for good site management system while there are more layers of approval in the process
• Benefit from site portal that can be central communication tool for all study related documents, vendor manuals, training and site communications
• Learn how to fully brief site coordinators for new offerings so they can comfortably present the benefits to patients that leads to better patient cooperation and retention

• Australia’s scientific talent, excellent medical infrastructure and lucrative R&D cash refund scheme makes it a preferred destination for early phase clinical trials
• Patient availability makes Asia a key region to accelerate later phase development, at lower costs
• The partnership between regional specialists, an alternative to large global CRO to manage complex global trial

• Understand the FDA’s requirements and guidance for quality clinical trials
• Explore how you can ensure that quality is owned by all stakeholders and integrate it into the company-wide culture
• Create an environment that values and rewards critical thinking towards quality management

• Identify how clinical operations can proactively raise quality questions and embed quality considerations into every aspect of the trial design
• Consider how QA can maintain the necessary level of impartiality while minimising internal siloes

• Highlighting challenges which companies may face with the implementation of new regulation
• Overcoming the regulatory demands of digital clinical trials
• How the Danish Medicines Agency and pharma can work together to bring more drugs to trial

• Digital Trial Start-Up Automation: AI-powered eTMF & CTMS
• Learn about eTMF and CTMS engagement paths for clinical documents executed via digital AI-driven processes
• How can AI speed up processes by anticipating and initiating next steps
• Detecting trends in quality and automating analysis through AI tools
• Utilising AI to enhance oversight and predicting trial timelines and approvals
• Managing TMF content seamlessly and accurately while maintaining inspection readiness and compliance

• How to collaborate with all relevant stakeholders to develop patient centred solutions for clinical trials
• Leveraging patient involvement at an early stage to meet patient needs by seeking and acting on patient feedback
• Design patient focused clinical trial technology together with the patient

Roundtable 1 Discuss the implemented effect of Brexit to understand impact it has on Nordic nations running trials in the UK

Bente Jackobsen, Senior Clinical Trials Supply Coordinator, Orphazyme

Roundtable 2 Discover how new and innovative technologies, like blockchain can influence data acquisition and data monitoring to give real time updates of the clinical supply chain

Merete Schmiegelow, Patient Representative, EUPATI

Roundtable 3 Discuss the changing responsibility between clinical supply and operations to ensure to trial drugs and medical devices are in the right place at the right time

Roundtable 4 Discuss common challenges and questions surrounding the integration and operation of key clinical systems for medical devices

Roundtable 5 Discuss how you manage your partnership model: Highlight what clinical supply functions should be kept in-house VS outsourced

• Establishing a model to enable integration of internal and external stakeholders for better process management
• Determining what tools and internal resources are needed to make operating models work
• Creating tailored processes for each trial and stakeholder which meet the needs of all users
• Exploring how to link multiple departments to facilitate trial success

• Illustrate how digital software can improve patient recruitment and retention
• Strategically pinpoint which areas of supply chain need to be upgraded to ensure long term engagement with patients
• Foster the adoption of new digital tools to support your clinical trial design to minimise cost and time
• Use block chain technology to track events with full transparency, accurately reproduce and share data, overcome privacy concerns and help improve patient enrolment strategies

The exhibition will feature a varied line-up of innovative technologies to support the Nordic life sciences sector.

No matter your job function you’ll find providers to meet your needs; we’ll be showcasing new solutions for trial operations, supply and beyond to give you a comprehensive suite of solutions to maximise trial success.

• Examine the impacts of the IVDR regulation and understand why it will be a game changer for IVD devices
• Introduction to the new requirements for clinical evidence
• Understand how to prepare for the IVDR implementation

• Understand the benefits of using EDC system to ensure smooth oversight of the study process and reporting
• Discover how to effectively collect clinical data in electronic formats to replace traditional paper based data collection methodology
• Eliminating redundant data entries: Exploring how to combine various data sources for valuable clinical trial outcomes
• Understanding increased requirements on clinical evidence and what help can put you on fast track

• Identifying which devices are best suited to RCT and the best steps for accurate, comparable trial results
• Over-coming patient recruitment challenges for RCT – identifying and attracting enough patients to ensure accurate results

• Compliment your RCT with Real World Evidence to strengthen trial results

• Map out what should be outsourced and internally resourced to improve operational efficiency
• Build internal platforms to communicate for smooth operation and share ideas for innovation
• Expand your network in your community to keep up to date of new strategic planning method
• Design a strategy to expedite patient recruitment and run the studies to get to market as quickly as possible under budget pressure

• Understand the most efficient and effective process for accurate approval process before being introduced to the market
• Investigate how to manage responsibility issue between you and your partner for each aspect of the trial
• Build an evidence base depending on the categories of medical devices classified according to your patient’s risk
• Showcase how to overcome the obstacles which may affect novelty and delay process