Society for

Clinical Research Sites

410.696.5080 | MySCRS.org

Christine Pierre, President | christine.pierre@myscrs.org

Industry Realities

• Lack of communication between

stakeholders and sites

• Poor predictability of site

performance

• Unpredictable recruitment

performance

• Diminishing investigator pool

• 30.6 B global enterprise by 2015

410.696.5080 | MySCRS.org

Challenging Reality at Sites Today

Source: Tufts 2013

32-47% of sites will perform only one study and exit the industry

The average site performs only 4 studies per year

Inconsistent quality and performance of sites

across the globe

30% of sites provide

70% of all study subjects

410.696.5080 | MySCRS.org

People Are Talking…About Sites Association for the Accreditation of Human Research Protection Programs (AAHRPP)

Accredits high-quality human research protection programs in order to promote excellent, ethically sound research.

Alliance for Clinical Research Excellence & Safety (ACRES)

Site accreditation, Define site-based performance metrics and system-wide informatics standards, Reengineering clinical research to develop a common understanding of quality drivers and human factors underlying management and organization of processes.

Association of Clinical Research Organizations (ACRO)

CRO Trade Association

Biotechnology Industry Organization (BIO) Worlds largest biotechnology trade association.

410.696.5080 | MySCRS.org

Clinical Data Interchange Standards Consortium (CDISC)

Established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. To develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

C-Path

Improves efficiency of the development of drugs, diagnostics, and medical devices by creating new data standards, measurement standards, and methods standards. Establishing these standards streamlines the regulatory submission process. As a trusted and neutral third party, C-Path then works closely with FDA, EMA, and other regulatory agencies to accelerate the final review process to bring new, safer products to market faster.

Clinical Trials Transformation Initiative (CTTI)

Identify practices that will increase the quality and efficiency of clinical trials.

Food & Drug Administration (FDA) & other federal agencies

410.696.5080 | MySCRS.org

NIH’s Health Care Systems Research Collaboratory

Joint venture of the DCRI, the Harvard Pilgrim Health Care Institute, the Group Health Research Institute (GHRI), Johns Hopkins University, and the Center for Medical Technology Policy (CMTP). Intended to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research. The ultimate goal is to ensure that physicians and patients are able to make decisions based on the best available clinical evidence.

Institute of Medicine (IOM)

Discussing site accreditation.

Metrics Champion Consortium (MCC)

Help sponsor and service provider organizations involved in the pharmaceutical, biotechnology and medical device industries improve their overall clinical trial development processes through the utilization of MCC standardized clinical trial performance metrics (time, cost & quality)

410.696.5080 | MySCRS.org

Pharmaceutical Research and Manufacturers of America (PhRMA)

Pharmaceutical Companies’ Trade Association

Secretary's Advisory Committee on Human Research Protections (SACHRP)

OHRP supports the SACHRP which advises the HHS Secretary on issues of human subject protections.

TransCelerate

A group of the world’s largest pharmaceutical companies agree that they would cooperate on research aimed at accelerating drug development, starting with streamlining clinical trials in the pre-competitive market space.

And this is not an inclusive list!

The One Stakeholder Not At the Table… The Sites

410.696.5080 | MySCRS.org

History and Foundation of SCRS

Now in its 9th year, the Site Solutions Summit is dedicated exclusively to helping clinical research

sites reach optimal performance. The Site Solutions Summit is now the annual meeting of SCRS.

410.696.5080 | MySCRS.org

2012 Launched

Society for Clinical Research Sites

Trade Organization

410.696.5080 | MySCRS.org

Mission:

Unify and amplify the voice of the global

clinical research site community for site

sustainability.

SCRS Membership Benefits Available to all member employees

Advocate Connect Educate Mentor

410.696.5080 | MySCRS.org

SCRS Membership Benefits Available to all member employees

Advocate Connect Educate Mentor All members’ perspectives and voices will be represented by SCRS to regulatory agencies and industry stakeholders.

Member sites will have a full site profile page within the SCRS Site Directory. The SCRS Site Directory is available to all sponsors and CROs seeking sites for future studies.

Good Clinical Practice training and documentation - Collaborative Institutional Training Initiative (CITI)

All members have the ability to offer and receive mentoring by fellow members on business solutions and marketplace challenges.

Participate in Site Advocacy Groups (SAGs).

Global Site Solutions Summit. Oct 10 – 12 – Florida European Site Solutions Summit March 2015 – Croatia

Participate in our monthly webinar series, offering one CEU/attendee 12 Good Business Practices (GBP™) 12 Good Clinical Practices (GCP).

Participate in SCRS’ listserv Investigators Only Executives Staff

Participate in SCRS communities and nominate the sponsor and CRO of your choice for the Eagle Award.

On Line Training The Hidden Costs of Conducting Clinical Research at the Site Inspection Readiness Six Segments of Successful Site Management Investigator Training & Mentoring

SCRS’ Document Library where members share valuable documents.

Use of SCRS’ logo on your print and electronic marketing material

Receive SCRS’ annual white paper Site Patient Recruitment Innovation Award - SPRIA

Responsible Site Management ™ and site score card.

Subscription to InSite, SCRS’ global quarterly journal

410.696.5080 | MySCRS.org

SCRS Membership Today…

1,400 32 Sites Strong & Growing Countries Represented

410.696.5080 | MySCRS.org

New

Zealand

India Egypt Philippines Vietnam Columbia France Nigeria Iraq Turkey

Joined This Weekend

Site Membership Demographic • In business on average 14 Years

• Represents ~14,000 Investigators

~12,000 Research Staff Members

• Type of Sites ~ 3% Academic/Hospital

~ 97% Practice & Freestanding

~ 1% Developing Countries

~ 7% Emerging Sites (Gross Revenue < 250M annually)

• Geographic Distribution – 93% US

– 7% OUS

• Experience / Capabilities – All Therapeutic Areas

– Drugs, Devices & Biologics

– All Ages Available

410.696.5080 | MySCRS.org

Creating Industry Partnerships Global Impact Partners

410.696.5080 | MySCRS.org

SCRS’ Achievements Year One • Responded to request for comments to 3 agency guidance documents (2 FDA, 1 EMA)

• Attended FDA/CITI meeting on PI Training – comments from CTTI/agency forthcoming

• Obtained ANCC accreditation – can now offer CEUs

• Multiple Presentations & Meetings expressing the sites views on various topics

• Risk Based Monitoring and It’s Impact on the Sites – Published article and White Paper

• IOM – Site Accreditation – co-led the governance committee

• Launched SCRS Site Directory

• CITI Project approved to determine reason and cost of Investigator turnover

• Site Advocacy Groups - grew from work with TransCelerate work streams

• Scholarship Program

• Responsible Site Management ™ - multi stakeholder initiative to identify the 12 best site practices and desired metric to measure against

• Site Quality Program – Beta testing currently

• Invitation to Gates Foundation

410.696.5080 | MySCRS.org

2014/2015 Initiatives Site Sustainability SCRS Growth 1. Training Webinars w/CEUs Site Management Manual

2. Site Directory 3. Site Advocacy Groups (SAG) 4. Responsibly Site Management ™ Establishing Site Standards

5. Site Solutions Summit Global Summit October 2014 European Summit – March 2015

5. Position Papers Cost of Investigator Turnover RBM & It’s Impact on the Sites Training & Audit Findings Quality & Compliance From The Site’s View

1. Scholarship Program 2. Establishing relationships with existing

groups for collaboration 3. Needs assessment of global site

community 4. Raise awareness of SCRS

410.696.5080 | MySCRS.org

Site Membership Types

410.696.5080 | MySCRS.org

Be Site Strong

Join SCRS

410.696.5080 | MySCRS.org