powerpoint template - july 2015 - acrp.be conference · authorities and other industry stakeholders...

TransCelerate OverviewUpdated 26,October 2016

TransCelerate

Background

Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 3

TransCelerate is a not for profit entity created to

drive collaboration

Our visionTo improve the health of people around

the world by accelerating and simplifying

the research and development of

innovative new therapies.

Our missionTo collaborate across the global research

and development community to identify,

prioritize, design and facilitate

implementation of solutions designed to

drive the efficient, effective and high

quality delivery of new medicines.

Founded in 2012 by

10 Members

http://www.bms.com/

http://www.lilly.com/

http://www.roche.com/index.htm


TransCelerate Today – 18+ Organizations and 15

Active Initiatives

2012

2013

2014

Today

10 Founding Members

5 Active Initiatives

17 Member Companies


1 exploratory Initiative

17 Member Companies


1 Exploratory Initiative

18 Member Companies


2 Realized Initiatives


Engage with Key Stakeholders

We also recognized the need to collaborate not only across participating Member Companies, but also regulatory authorities and industry groups.

Research and

CRO Community

Industry Initiatives

Regulatory

Authorities

Investigator Sites

http://www.aaci-cancer.org/index.asp

http://sitesolutionssummit.com/wp-content/uploads/2012/01/SCRS-Logo_web600px_medium.png

http://www.pmda.go.jp/english/index.html

http://www.jcroa.gr.jp/eng/index.html

TransCelerate

Project Portfolio

Overview


TransCelerate Strategic Priorities

Improve the Site Investigator Experience

Facilitate Information

Sharing

Enable Harmonization of Clinical Trial

Processes

Enhance Sponsor

Efficiencies

Improve the Patient

Experience

Improve the Site Investigator Experience as they work with Sponsors to execute Clinical Trials.

Facilitate the sharing of clinical trial related information as appropriate amongst industry stakeholders, focused on exchanges of information that would enable the industry to capture efficiencies.

Enable the industry to move toward greater harmonization of clinical trial processes to facilitate the advancement of technologies and processes within the broader clinical ecosystem.

Through collaboration, streamline redundant sponsor activities to reduce investigator and Patient burden, while refocusing resources to drive and deliver innovative drugs to patients faster and safely.

Improve the Patient Experience by decreasing patient burden, enabling a better informed patient and improving clinical research awareness, study participation and engagement.

TransCelerate assesses industry challenges and selects initiatives

aligned with our five strategic priorities:


TransCelerate’s Portfolio of Initiatives

TransCelerate’s Portfolio of Initiatives focus on Increased Efficiencies,

Patient Safety, and Accelerated Development Timelines.

Clinical Trial Diversification

Pediatric Trial Efficiencies

Active

Design,

Develop,

& Deploy

Phase

Realization PhaseRealization

PhaseClinical Trial

Diversification

Pediatric Trial

Efficiencies

Site Qualification

and Training

Shared Investigator

Platform

Risk Based Monitoring

Quality Management

System

Clinical Research

Awareness &

Access

Investigator RegistryeLabels

Comparator Drugs

Clinical Data Standards

Clinical Data Transparency

Common Protocol

Template

eConsent eSource

Placebo / Standard of

Care Data

Sharing

Patient Experience

&

Technology


Designed a model Risk Based Monitoring Methodology for use by industry.

Operationalized a program for mutually recognizing Good Clinical Practice (GCP) training across sponsors to eliminate sites taking duplicative training.

Developed a series of templates/forms for Sites to create value and streamline processes

Launched the Shared Investigator Platform & Investigator Registry for use by Member Companies to improve and streamline interactions with Investigator Sites.

Operationalized a network of TransCelerate Member Companies to secure Comparator Drugs for studies from each other.

Collaborated through CFAST to publish 22 Therapeutic Area Data Standard User Guides.

Developed and published a Common Protocol Template and made publicly available on the TransCelerate website.

Published a model approach for Data De-identification and Anonymization of Individual Patient Data in Clinical Studies.

Published Clinical Quality Management System Concept, Issue Management and Knowledge Management papers in DIA’s Journal (TIRS).

Launched BioCelerate - A subsidiary of TransCelerate focused on preclinical collaboration.

*Note: Adoption of TransCelerate solutions are voluntary

Significant Accomplishments To Date


Stay Informed and Engaged

Email: [email protected]

• Send questions, comments at any time

Twitter: @transcelerate

• Industry articles and updates

LinkedIn: TransCelerate BioPharma Inc.

• Industry articles and updates on our initiatives

Newsletter & Monthly Emails

• Sign up on our website to hear from us!

mailto:[email protected]

Appendix


Workstream Objective

Clinical Research

Access & AwarenessClinical Research Awareness and Access seeks to increase awareness of and

education about clinical research and its impact, improve potential participants

access to clinical study opportunities and information on available studies, and

enable more meaningful sharing of information with study participants.

eLabels The eLabels Initiative will help the industry progress on the journey to digitally-

supported, patient-centric clinical supply chains. eLabels are expected to enhance

patient and site utility, promote consistent, up-to-date information and be a

catalyst for future digital clinical supply transformation.

eConsent The eConsent Initiative will facilitate broad, voluntary adoption of eConsent by

describing a framework/guidance for eConsent digital components and a toolkit

to aid sponsor implementation . Successful industry adoption of eConsent will

empower patients, caregivers and the providers that care for them, while

increasing regulatory compliance and reducing quality risks.

Patient Experience &

Technology

The Patient Experience and Technology (PE&T) Initiative will help the industry

understand (and measure) the patient’s clinical trial journey. With this

understanding, the initiative can better facilitate the acceleration of technology

solutions that specifically target and reduce patient burden and improve the

patient experience in clinical trials.

Active Initiatives with the Shared Goal of Innovative

Operational Approaches to Speed Progress on Patient-Centered Clinical Trials

http://www.transceleratebiopharmainc.com/initiatives/patient-awareness-and-access/

http://www.transceleratebiopharmainc.com/initiatives/elabels/

http://www.transceleratebiopharmainc.com/initiatives/econsent/



Investigator

Registry

The Investigator Registry Initiative will create a shared

repository of investigator contact details and some site-related

data from consenting investigators and sites, accelerating the

identification and recruitment of qualified investigators and

reducing cost and trial length by avoiding duplication of

common study start-up processes.

Site Qualification

and Training

The goal of the Site Qualification and Training Initiative is to

enhance and simplify the clinical trial site qualification and

training process by creating programs, tools and resources

that reduce time spent on non-study specific tasks, allowing

more time to focus on patients.

Shared

Investigator

Platform

The Shared Investigator Platform (SIP) will reduce the burden

on sites by providing them with a central point of access,

harmonized content and services, and streamlined interaction

with participating clinical trial sponsors.

Active Initiatives with the Shared Goal of Decreasing

the Burden on Investigator Sites

http://www.transceleratebiopharmainc.com/initiatives/investigator-registry/

http://www.transceleratebiopharmainc.com/initiatives/site-qualification-and-training-sqt/

http://www.transceleratebiopharmainc.com/initiatives/shared-investigator-platform/



Clinical Data

Transparency

The Clinical Data Transparency Initiative was formed with a mission of

developing a model approach for redacting privacy information found

in clinical study reports and a model approach for the anonymization of

patient-level data shared with the broader healthcare community. This

initiative will help sponsors more efficiently meet regulatory requirements

regarding data transparency and enhance transparency and facilitate

future research preserving the privacy of patients, investigators and

clinical trial staff for operational transparency issues related to privacy.

eSource The eSource Initiative will help accelerate the uptake of eSource for

clinical trials, assisting trial sponsors in overcoming real and perceived

challenges to influence more efficient data gathering practices, which

will benefit patients, sites and sponsors.

Risk Based

Monitoring

By developing a scalable model approach for risk-based monitoring of

clinical trials, TransCelerate’s objective is to both enhance patient

safety and ensure the quality of clinical trial data.

Quality

Management

System

The Quality Management System Initiative aims to explore ways to

improve quality across the industry through partnerships with health

authorities and other industry stakeholders - which can enhance patient

safety by improving quality, assuring data integrity, minimizing delays in

clinical trials and bringing drugs to market faster.

Active Initiatives with the Shared Goal of Streamlining

redundant sponsor activities, while refocusing

resources to drive and deliver innovative drugs

http://www.transceleratebiopharmainc.com/initiatives/clinical-data-transparency/

http://www.transceleratebiopharmainc.com/initiatives/esource/

http://www.transceleratebiopharmainc.com/initiatives/risk-based-monitoring/

http://www.transceleratebiopharmainc.com/initiatives/quality-management-system/



Clinical Data

Standards

The Clinical Data Standards Initiative, in collaboration with CDISC (Clinical Data

Interchange Standards Consortium), C-Path (Critical Path Institute), NCI-EVS

(National Cancer Institute—Enterprise Vocabulary Service) and FDA as part of

the CFAST (Coalition For Accelerating Standards and Therapies), aims to

establish therapy area (efficacy) data standards to support the exchange and

submission of clinical research and meta-data, while improving patient safety

and outcomes.

Common

Protocol

Template

The Common Protocol Template Initiative works with industry stakeholders to

create a model clinical trial protocol template containing a common structure

and language, to reduce protocol development time, regulatory review, and

improve end to end data flow, while making protocols more user-friendly for

investigators and patients.

Comparator

Network

The Comparator Network Initiative established a reliable, rapid sourcing of

quality comparator drug products for use in clinical trials through a Comparator

Supply Network, which enables accelerated trial timelines and enhanced

patient safety.

Placebo /

Standard of

Care Data

Sharing

The Placebo and Standard of Care Initiative was established to enable the

sharing of data to maximize the value of clinical data collected historically in the

placebo and standard of care control arms of a clinical trial. Our goal is to

enhance clinical trial designs, develop disease models and improve patient

recruitment.

Active Initiatives with the Shared Goal of facilitating

the sharing of clinical trial related information as

appropriate amongst industry stakeholders

http://www.transceleratebiopharmainc.com/initiatives/clinical-data-standards/

http://www.transceleratebiopharmainc.com/initiatives/common-protocol-template/

http://www.transceleratebiopharmainc.com/initiatives/comparator-network/

http://www.transceleratebiopharmainc.com/initiatives/placebo-standard-of-care/


SCRS Represents

50%

28%

14%

8%

Practice

Freestand

ing

Hospital

Academi

c

4,000+ Sites Strong & Growing

79% US 11% Emerging

21% ROW 2% Developing Countries

Drugs • Devices • Biologics

100,000 Research Site Professionals

54 Countries


Copyright PT&R/ VvdW17


The Shared Investigator

Platform (SIP)

…..will reduce the burden on sites by

providing them with a central point of

access, harmonized content and

services, and streamlined interaction

with participating clinical trial sponsors.

18


Portals/Vendors

• Same vendor, different access

• Same vendor, new training

• Same sponsor, different vendors

• Vendor collaborations mid of a trial -> new portal

19


Overview of portals usedAccovion https://rdconsite.accovion.biz

Aldays www.aldaystudy.com

trainingen, visiteplanning,

recruitmentupdates, studiedocumenten

Bioclinicafusie met Synarc QC

dexa

Cenduit https://www.cenduitsolutions.com IWRS

Citrix https://citrix.accovion.biz/Citrix

Clinphone via Mytrials https://www.mytrials.com IWRS, accountability

Clinphone http://www.clinphone.com

Covance http://www.covance.com lab

Datatrak https://secure.datatrak.net eDC

ePharmasolutions https://dstops.epharmasolutions.com trainingen, safety letters

EPX by ERT myeprodata.comsubject

information/trainingsubject

information/training

ERT https://mystudy.ert.com ediaries ECGs ediaries ECGs

Firecrest https://www8.firecrestclinical.com training training training training

Greenphire facturatie

HMD clinical https://irt.hmdclinical.com IWRS

Icophone https://flex.iconolc.com IWRS

ICTI www.icti-glabl.com/IXRS

Impala IWRS

Inform https://www.pacetrials.com eDC (6.0) eDC (V5.5) eDC (V5.5) eDC (V5.5)

Infosario https://infosario.quintiles.com lab lab lab

Isis https://isis.parexel.com

L2T https://link2trials.com recruitment recruitment recruitment

Labcorp https://siteportal.corelabpartners.com

Masterscope spirometry

Medidata Rave https://login.imedidata.com eDC

Medrio https://login.medrio.com eDC

Merge webbased https://portal.etrials.com Compliance dagboek

Merge telefoon Dagboek activatie

Mercklearning https://www.mercklearning.com/plateau/user/login.do study info / training

Mylessons https://access.gsk.com/selfservice

Mytrials https://www.mytrials.com

Oracle https://rdc.pfizer.com/rdcadfsrnd/faces/Login? eDC

Oracle IRT https://irt5.webcrf.net/apps/login.aspx eDC

Parexel dicom http://parexel.dicomgrid.com

Perceptive https://www.mytrials.com/wps/myportal

Perceptive dicom https://perceptive.dicomgrid.com

PHT https://mystudy.phtstudy.comediaries, trialslide, mini via

website van PHT

PPD in site https://sites.ppdi.com/SitePortal/

Q lab ECG

Quest lab lab

Ramos IVRS IVRS

SMSservice center https://smsservicecenter.nl recruitment recruitment

Strength study portal https://strengthtrial.com

Patienten materialen,

visite planner, social media

StudyKIK portal https://studykik.com/login/ recruitment

Synarc https://synarcconnect.com

TrialMax https://trialmax.crfhealth.net

Trial-on-line https://probi.trialonline.net eDC

Trident https://grunenthal.iwr.bioclinica.com/trident

TSS Portal GSK medicatie medicatie

TTCweb

http://www.aldaystudy.com/

https://www.cenduitsolutions.com/

https://citrix.accovion.biz/Citrix

https://www.mytrials.com/

http://www.clinphone.com/

http://www.covance.com/

https://secure.datatrak.net/

https://dstops.epharmasolutions.com/

https://www8.firecrestclinical.com/

https://irt.hmdclinical.com/

https://www.pacetrials.com/

https://infosario.quintiles.com/

https://link2trials.com/

https://login.imedidata.com/

https://login.medrio.com/

https://portal.etrials.com/

https://access.gsk.com/selfservice

https://www.mytrials.com/

https://rdc.pfizer.com/rdcadfsrnd/faces/Login?

https://mystudy.phtstudy.com/

https://strengthtrial.com/

https://trialmax.crfhealth.net/

https://probi.trialonline.net/

https://grunenthal.iwr.bioclinica.com/trident


Clinical Research Awareness

and Access (CRA & A)

……seeks to increase awareness of and

education about clinical research and its

impact, improve potential participants

access to clinical study opportunities and

information on available studies, and enable

more meaningful sharing of information with

study participants.

21


• Tools, tools, tools

• Mentoring

22


eConsent

…….will facilitate broad, voluntary adoption of

eConsent by describing a framework/guidance for

eConsent digital components and a toolkit to aid

sponsor implementation . Successful industry

adoption of eConsent will empower patients,

caregivers and the providers that care for them,

while increasing regulatory compliance and

reducing quality risks.

23


• Consistency

• Amble amount of time

• Version controle

24


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powerpoint template - july 2015 - acrp.be conference · authorities and other industry stakeholders...

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