Outsourcing in Clinical Trials Eastern Europe 2021
DAY 1|15th June 2021
11:30 am Case Study: Taking a Virtual Clinical Trial to Eastern Europe
We welcome Matus Hajduk to discuss the virtual clinical trial they took to Eastern Europe; its challenges and successes, including:
- Technology as an instrument for success: examining the digital tools used
- A look at the infrastructure of sites in Eastern Europe – what were the challenges encountered?
- Lessons learnt moving forwards and advice for other biotechs launching virtual trials in the Central or Eastern European region
Senior, Digital Clinical Operations
12:00 pm Best practices in outsourcing translation services for clinical trials in CEE
This session will build on Nordtext’s 15 year experience in managing language services for Nordic and CEE markets and will discuss the following main topics:
- How to choose the most suitable multilingual support strategy for your trials in CEE?
- How to choose the right translation services partner?
- How to achieve operational efficiencies, maintain linguistic quality and decrease translation costs?
12:30 pm Working Effectively with Medical Translators and how this is key to successful studies in Eastern Europe
When siting studies in a new region, ensuring medical documents are correctly translated is key. In this talk, Claudia Soronellas-Brown, Translation Manager at Stanford Healthcare will discuss:
- How to partner for maximum value – have a clear strategy
- Observing the correct medical terminology and ensuring the language is clear and translated correctly
- Linguistic validation – back translation, reconciliation, cognitive debriefing
1:00 pm How to upgrade your clinical trial logistics in Eastern Europe through a strategic partnership
- Getting the best from the partnership approach: why trust and flexibility matter
- 3 main steps to building trust: relationship, quality and compliance
- Understanding the benefits of process transparency
- Case Studies: Direct-to-Patient and Cell and Gene Therapy Logistics Platforms
Business Development Manager
World Courier Israel
1:30 pm Innovation in sponsor oversight: Planning, managing, documentation, and data. A real live experience report
- Innovative ways to inspection readiness in sponsor oversight
- Integrate all stakeholders (Trial Management, Data Management and Statistics, and PV) into the oversight process
- Integrating oversight process and business intelligence on trial data
Head of Clinical Data Management and eClinical Systems
2:00 pm Why are Central and Eastern Europe the hottest locations for clinical research?
- Benefits of situating your trial in Eastern Europe as opposed to Western Europe or the US including a review of budget and patient recruitment considerations
- Discussing when to partner with a regional CRO including the benefits that local expertise can have
- Tips on vendor negotiation when working in Eastern Europe – ensuring you get the best deal!
- Debunking the negatives on working in Eastern Europe and overcoming the challenges
2:30 pm The importance of translation & localization in Eastern or Central European clinical trials – taking a holistic approach
When expanding your trials to a new region, such as Central & Eastern Europe, it is important to ensure that your trial is fully accessible to local patients and partner organisations. This talk will therefore cover:
- Understanding the value of localization in clinical trials and how it drives the need for quality medical translation
- The difference between translation and localization in ensuring not only linguistic transfer but also content, cultural, and technical issues
Translation Services Manager
3:00 pm CEE to the Rescue - Leveraging Central and Eastern Europe to Save Enrollment Timelines
This session will cover the attributes of Eastern Europe which make it an excellent source for patient enrollment and how the region can be best utilized to ‘rescue’ underperforming clinical trials. We will review the strengths/weaknesses of different countries in the region and strategies for maximizing the potential for a variety of situations, using actual case studies.
Dana Leff Niedzielska
3:30 pm Embracing Disruption in Pharma – is COVID-19 a Catalyst for Lasting Change?
We welcome Dr. Bonnie Bain from GlobalData to present her research into the state of the Biopharmaceutical Industry in 2021. Including:
- Identification of key themes that were triggered by COVID-19 and how they are shaping the biopharmaceutical industry – both today and into the future
- Key emerging technologies & disrupters
- Industry, regulatory and macro-economic factors affecting pharma in 2021
Don’t miss this talk; it is crucial for the biopharmaceutical industry to recognize the factors shaping the clinical trial landscape in order to maximise their future success.
Global Head and Executive Vice President of Healthcare Operations and Strategy
4:00 pm How Managing a standardized outsourcing process allows a transparent and duly motivated bidding process – focusing on Eastern Europe
Benefits of a centralised outsourcing process including more consistent pricing, time reduction for selection, outsourcing experts and maintenance of a global repository of vendors. The process for the identification and selection of Vendors includes:
- Establishment of Vendor requirements
- Identification of potential Vendors
- Evaluation of potential Vendors including risk assessment
- Selection of final Vendors
- Approval of the selected Vendor
- Contract with the selected Vendor
Senior Manager, Responsible Global Outsourcing and Contract Management Europe, Global Medical & Regulatory Affairs
4:30 pm Standards of Care and Treatment Availability Across CEE
The CEE region has long been known for the high enrollment potential of motivated patients. In order to take advantage of this potential it’s important to consider current treatment options within the region and how protocol requirements for specific pre-treatment, comparators and patient pathways affect this. We will be looking at some of the options available for oncology, infectious disease and dermatology clinical trials.
Chief Business Officer
EastHORN Clinical Services
5:00 pm Roche Ukraine Case Study: Blockchain in the Pandemic and the “New Normal”
We welcome Sava Palamar from Roche to discuss how Roche have been using blockchain during the COVID-19 pandemic, including how it helped them carry
5:30 pm PANEL DISCUSSION - Hindsight is 2020: Exploring the Impact of a disrupted 2020 on the Central and Eastern European Clinical Trials Industry
After the disruption of 2020 (and early 2021!), we are offering this opportunity for the industry to come back together to share ideas and reflect on the past year. Join this informal discussion session to share your experiences and thoughts on the challenges and successes since the pandemic began.
Discussion points include:
- 2020 and COVID-19: how did we do? How badly impacted were your trials?
- How did you find remote working? What are the positives and negatives of the ‘new normal’?
- How has COVID impacted our patients, partners and businesses
Dana Leff Niedzielska, CEO, August Research
Rozalina Lapadatu, President, Autoimmune Disease Patients Association Romania
Sava Palamar, Digital Projects Lead, Roche Ukraine
Moderator: Revati Tatake, Global Director of Databases and Analytics, GlobalData Healthcare
Further panelists welcome – please apply
Dana Leff Niedzielska
Autoimmune Disease Patients Association Romania
Digital Projects Lead
6:15 pm GROUP DISCUSSION SESSION - Expanding Clinical Studies to Eastern Europe: Best Practices and Main Considerations
This discussion will focus on the key considerations and challenges that come with expanding trial operations into Eastern Europe.
- Regulatory considerations that need to be taken into account when US or Western European companies expand into the arena – and how to ensure home regulators will accept data obtained abroad
- Exploring how cultural differences can impact your trial and how to translate your trial to fit different cultures
- The potential benefits of expanding into Eastern Europe including reaching larger populations and avoiding local lockdowns
- The challenges that can come with working in Eastern Europe and how to overcome these challenges
This will be an interactive session with the audience encouraged to join in with the discussion
Study Start-Up Manager
7:00 pm Close of event
OCT Eastern Europe offers a leading platform for solution providers to raise awareness of their solutions to the pharmaceutical and medical device industry. Opportunities include thought leadership, exhibition space, private drinks and dinner networking events and much more. To enquire about sponsorship opportunities for the conference, please contact our commercial team at:
Head of Sales – OCT Europe
T: +44 0207 9366 690
The 2021 programme is written in collaboration with industry, if you have a case study, idea or just a comment, please contact:
Senior Conference Producer
T +44 (0) 20 7832 4323