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14TH ANNUAL OPTIMISING CLINICAL TRIALS SUMMIT: SITE SELECTION, FEASIBILITY & PATIENT RECRUITMENT

18 – 19 NOVEMBER 2020 | ONLINE
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PAST SPEAKERS

SEE THE PREVIOUS SPEAKERS & CASE STUDIES

Luigi
PETILLO

Clinical Information Science Director

Oleksandr
GORBENKO

Global Patient Centricity Director

Ekkehard
BROCKSTEDT

Head of Team Outsourced Trials, Corp. Div. Medicine

Marta
GARCIA MANRIQUE

Patient Officer, R&D

Claus
GOEBEL

Head Country Clinical Operations Germany & Switzerland

Maarten
BOOMSMA

Clinical Study Director

CONFERENCE TOPICS 2020

LOOK AT THE TOPICS THAT WERE DISCUSSED

  • Platform trials – How to run them successfully?
  • The new era of virtual trials and real-world evidence
  • Shared Investigator Platform (SIP) – A new way of customer-centric study management
  • Clinical trial transparency and patient centricity
  • Patient-centred protocol – What does it look like?
  • Are patient-centricity and regulatory requirements compatible?
  • LEO Innovation Lab – Sharing virtual clinical trial experiences
  • CRO – Is sponsor innovation still feasible in clinical trials?

DESIGNED FOR

Members of board, C-level, Senior/Global Vice Presidents, Directors, Heads of departments from pharmaceutical industry involved in:

  • Clinical Trials
  • Clinical Development
  • Virtual Trials
  • Hybrid Trials
  • Clinical Operations
  • Clinical Innovation
  • Research & Development
  • Clinical Study
  • Protocol Optimisation
  • Clinical Trial Transparency
  • Study Start-up
  • Data Management
  • Patient Recruitment
  • Site Selection and Feasibility
  • Clinical Regulation
  • Patient Centricity
  • Clinical Site
  • Clinical Project
  • Study Management
  • Clinical Sciences

CASE STUDIES

PAST CASE STUDIES INCLUDE

CASE STUDY / DAY 1

The New Era of Virtual Trials and Real-World Evidence: The Impact on Drug Development

Science has produced so much data in the last decades that nowadays, the difficulty is to be able to identify useful key information. The evolution of technologies and the speed of elaboration have finally made the handling of an enormous quantity of data more affordable. Nevertheless, new technologies have also changed people’s lives and habits.
We will try to understand what is the real impact of these changes on drug development and management of clinical trials: Opportunity or just an increase of difficulties?

  • Why has the era of virtual trial arrived?
  • Sharing of information and the need of using real-world evidence data
  • From virtual data to real-world data and vice versa
  • New technologies are a real opportunity or an increase of management difficulty?
  • Benefit/cost analysis of virtual trials

Luigi
PETILLO

Clinical Information Science Director

Maarten
BOOMSMA

Clinical Study Director

CASE STUDY / DAY 1

What Does a Patient-Centred Protocol Look Like?

Why is it so difficult to get a patient for a trial? And once recruited, why is it so difficult to keep the patient in the trial and on the study drug? Let us look at what discourages patients to get into, and remain in a trial. And with that in mind, what does an ideal patient-centred protocol look like? Are patient-centricity and regulatory requirements compatible?

  • The struggle of getting a patient interested in a trial
  • Keeping the patient in the trial and on the study drug: Difficulties connected with that
  • What discourages patients upfront, and while in the study?
  • What does the ideal patient-centred protocol look like?

CASE STUDY / DAY 2

Platform Trials – A New Way Forward?

Platform trials investigate multiple therapies simultaneously. By sharing and control subjects, time and costs of trials could be reduced by up to 50% – depending on certain preconditions – making platform trials one of the most promising innovations in modern clinical trial design.

  • Introduction to platform trials: 1 disease/ X compounds
  • Key benefits vs. key challenges
  • Where and when to use it?
  • What do we need to run them successfully?

Ekkehard
BROCKSTEDT

Head of Team Outsourced Trials, Corp. Div. Medicine

Claus
GOEBEL

Head Country Clinical Operations Germany & Switzerland

CASE STUDY / DAY 2

Shared Investigator Platform (SIP) – A New Way of Customer-Centric Study Management

The Shared Investigator Platform (SIP) will be presented with the advantages for both sponsors and sites. SIP is a worldwide cloud-based internet portal (run by Cognizant) with the goal of making the documentation effortless and the exchange of information for centres and sponsors in clinical studies more efficient.

  • Background TransCelerate and Cognizant
  • Introduction to SIP – How does it work?
  • Advantages for sponsors
  • Advantages to sites
  • Current usage worldwide

SPONSORS 2020

A SPECIAL THANK YOU TO OUR SPONSORS

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