CASE STUDYKNEE OSTEOARTHRITIS

Smart countries selection and effective project management lead to 100% of recruitment on time

A clinical endpoint study to prove bioequivalence of a topical agent administered in adult patients su�ering from Knee Osteoarthritis. The study involved a full scope of services, including Feasibility and Site Selection process, Sites Set-up and Contracting, Study Authorization, Clinical Monitoring, Medical Monitoring, as well as Data Management and Project Management.

4 CEE countries selected for the project execution, with vast recruitment potential and relatively low GDP per capita: Poland, Hungary, Romania and Ukraine

Background

Challenges

Solutions

Recruitment target of 1200 patients to be achieved

within a 9 month recruitment period

Timely drug import from US to EU and Ukraine,

including obtaining drug import licenses

Intensive monitoring Communication with large study team: 250 Investigators, Nurses

and Coordinators

Careful sites selection process, choosing motivated investigators with capacity to enroll large number of patients in parallel

E�ective project management and set-up process, leading to no delays in sites activation

Investigators’ meeting for investigators from 4 countries and e�cient trainings

Regular thorough clinical monitoring, ensuring proper quality of data

Implemented 24/7 operational execution management style

Close operation with Sponsor’s team from US

KNOWLEDGE TO RECRUITKNOWLEDGE TO RETAIN

KCR is a Contract Research Organization (CRO) providing strategic clinical development solutions for the pharmaceutical, biotechnology and medical device industries. We have the knowledge to recruit and the knowledge to retain patients. Our successful approach combines KCR’s geographic coverage and a portfolio of sophisticated recruitment tools that allow us to approach the most challenging projects with con�dence.

For more please visit www.kcrcro.com or contact us at info@kcrcro.com Copyrights © 2016 KCR All rights reserved

Results

359

107

202

308

426

523

609686

772

884

9651007

11051148

1227

13341388

1434 1434

0 1065

128

236

331

420495

550

644

726

825888 918

9871052

1132

1216 1217

0

200

400

600

800

1000

1200

1400

1600

49 51 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35Week No.

Recruitment Curve

cumulativescreened

cumulativerandomized

1434 pts screened/ 1217 pts randomized - 100 % recruitment goal met on time

41 contracted and actively recruiting sites within 4 countries

Screen failure rate signi�cantly lower than initially assumed

Contracted milestones achieved on time

Operational

Site Management Booster Tools

Lessons Learnt Meetings

Referrals

Resourcing

Site coordinator

Nurses/other resources, according to needs

External database search

Marketing

Marketing materials

Media campaigns

Study branding

Tools

PATIENT NO.