TransCelerate Q4 Reg Council Quiz

1. TransCelerate was founded in year ______ and now consists of ______ Member Companies?

2013, 19

2011, 20

2012, 20

2013, 25

2. In Summer 2019, this work stream launched two new tools, P-PET and SPFQ, which incorporates the patients voice into clinical trial design?

Patient Technology

Clinical Research Awareness

Patient Insights

Patient Experience

3. This work stream created a toolkit which includes a regulatory landscape assessment which can be used when implementing technologies into clinical trials. This team is also the proud owner of the Shared Insights Knowledge-base, which is a database comprised of member company feedback and lessons learned when implementing technology into a trial.

IGR (Interpretation of Regulations and Guidances)

Patient Technology

QMS

Comparator Network

4. This work stream routinely meets with the NIH to discuss opportunities to make clinical trials more accessible to patients. In fact, they even have a new tool launching in December that aims to improve the quality and patient focus of registration submissions to ClinicalTrials.Gov.

Clinical Research Awareness

Patient Experience

Clinical Research Access and Information Exchange

eSource

5. What Sprint is handing off their work to a standards setting body this month to develop into a standard?

Patient Standard of Care

Patient Experience

Common SAE

e-Source

6. This initiative is aiming to leverage historical trial data to positively impact, among other things, innovative study designs.

PSoC (Placebo Standard of Care)

Datacelerate

DDF

ASA

7. In 2020 this workstream plans to publish the results of analysis of guidances and regulations across topics such as data privacy and audit trails.

PSoC (Placebo Standard of Care)

IGR (Interpretation of Regulations and Guidances)

eSource

Comparator Network

8. This workstream will be piloting an online community to enable best practice sharing and get implementation leads and users quick answers to their questions about the solutions.

RBM

Patient Experience

eConsent

CPT

What is the TransCelerate Mission?

Our mission is to conduct effective advocacy for public policies that encourage the discovery of important, new medicines for patients by biopharmaceutical research companies. To accomplish this mission, we are dedicated to achieving these goals across the country.

To protect and promote the health of the population intervening in the risks associated with the production and use of products and services subject to health regulation.

To collaborate across the global biopharmaceutical 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.

To achieve greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

What is TransCelerate’s vision for the future?

Aspires to create a future state for clinical research where these challenges are no longer roadblocks to success — a vision consisting of healthcare providers (HCPs) that are activated and supporting patients along their healthcare and clinical research journey, where HCPs, sites and investigative staff are fully supported by trial sponsors, researchers have access to the data they need to improve study design, and medications are developed faster for patients in need.

Patients have access to high-quality, safe, and effective medical devices of public health importance first in the world. Consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make health care decisions.

To be nationally and internationally recognized as an institution that promotes health, citizenship and development, operating in an efficient and transparent manner demonstrating itself as a leader in the field.

Secure the highest level of Excellence in Performance in quality; Maintain a close Partnership with the stakeholders for the common benefit; Actively Contribute to International Harmonization of regulations, guidelines, and standards.