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    Pioneer - IM - Krakow - Study Team and Timelines

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    This document summarizes the teams, regulatory status, timelines, and enrollment for a clinical trial project called Pioneer. It outlines the members and roles of the Chiesi, Chiltern, and partnership teams working on the trial. Regulatory activities including approval timelines from competent authorities and ethics committees are shown for the 8 participating countries. Key clinical trial timelines are also provided, such as first patient in, last patient first visit, last patient last visit, and close out.

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    Pioneer - IM - Krakow - Study Team and Timelines

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    stefavut
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    This document summarizes the teams, regulatory status, timelines, and enrollment for a clinical trial project called Pioneer. It outlines the members and roles of the Chiesi, Chiltern, and partnership teams working on the trial. Regulatory activities including approval timelines from competent authorities and ethics committees are shown for the 8 participating countries. Key clinical trial timelines are also provided, such as first patient in, last patient first visit, last patient last visit, and close out.

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    04. Pioneer_IM_Krakow_Study Team and Timelines

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    This document summarizes the teams, regulatory status, timelines, and enrollment for a clinical trial project called Pioneer. It outlines the members and roles of the Chiesi, Chiltern, and partnership teams working on the trial. Regulatory activities including approval timelines from competent authorities and ethics committees are shown for the 8 participating countries. Key clinical trial timelines are also provided, such as first patient in, last patient first visit, last patient last visit, and close out.

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    100 views13 pages

    Pioneer - IM - Krakow - Study Team and Timelines

    Uploaded by

    stefavut
    This document summarizes the teams, regulatory status, timelines, and enrollment for a clinical trial project called Pioneer. It outlines the members and roles of the Chiesi, Chiltern, and partnership teams working on the trial. Regulatory activities including approval timelines from competent authorities and ethics committees are shown for the 8 participating countries. Key clinical trial timelines are also provided, such as first patient in, last patient first visit, last patient last visit, and close out.

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    of 13

    Team / Regulatory Status / Timelines /Enrollment

    Catherine FRANCISCO

    Chiesi Clinical Project Manager

    Krakow, 7-8 December 2016


    PIONEER CHIESI TEAM

    Eszter GADOLET
    Sonia Biondaro Clinical Trial
    Administrator
    Data Mgt

    Aida
    EMIROVA
    Maria Carmela Catherine Clinical Research
    PARADISO FRANCISCO Physician
    Clinical Trial Clinical
    Supply Project Mgt

    Giuliana
    GANDINI
    Debora SANTORO
    Pharmacovigilance
    Statistics Mirco GOVONI
    Clinical
    Pharmacologist

    2 | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |


    PIONEER CHILTERN TEAM
    Chiltern Data Manager Chiltern Regulatory &
    Evelyn Frech
    Catherine Site Services
    FRANCISCO Kathleen Adom
    Zuzanna Ostrowska-
    Programmer Clinical Janowicz
    Andrea Cook Project Mgt
    Chiltern Lead Statistician Chiltern
    Elisete Marechal Chiltern Project Mgt Medical Monitors
    Dr Kateryna Duda/
    Global Project Manager Dr Dana Romano/
    Dr Dusan Novakovic/
    Chiltern Technology Dr Ivana Mutafova
    Project Leader Sally Gray
    Oliver Stokes
    + Project Managers Chiltern
    Tech Trainers Catriona Thomson / Nataliia Karel/ Pharmacovigilance
    Call Centre Staff Stefania Abate
    Olena Rudovska

    Chiltern Clinical Team Leaders


    Sofie Agnieszka Philip Denis Sergiy Nataliia
    Corluy Musialek Sigalov Matsavey Bondarenko Oliinyk

    Belen Martin Lead Clinical Trial Assistant + Country CTAs

    3 Chiltern Country CRAs


    | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |
    3
    PIONEER CHILTERN MONITORING TEAM
    Chiltern Clinical Team Leaders
    Sofie Agnieszka Philip Denis Sergiy Nataliia
    Corluy Musialek Sigalov Matsavey Bondarenko Oliinyk

    CRAs

    UK – Marat Zhalovaga Germany – Elvira Schmidt, Katja Koehler

    Hungary – Dorka Kesjar, Zsofia Nagy, Nikolett Russia – Alena Germanova, Marina Ivanikova,
    Nagy Elena Shumova, Liudmila Demikhova, Irina
    Nikolett Nagy Klyatskaya, Michael Zavarzin
    Poland – Monika Dyskiewicz, Karolina
    Kazimierczak, Olga Witkowska, Leszek Konarski Romania – Octavian Alexe, Mariana Andron,
    Adina Paulescu
    Bulgaria – Hristo Dumanov, Yordana Alyakova,
    Martin Gotsev Ukraine – Anastasiya Klimashevska, Kira
    Polietaieva, Vladyslav Orlyk, Dmytro Bocharov,
    Angelina Astakhova, Dmytro Golub, Serhii Kulish,
    Volodymyr Kodolov

    4 | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |


    CHIESI PIONEER PARTNERSHIPS

    Investigational sites Catherine


    FRANCISCO

    Sally GRAY
    Amelie Grosjean
    (eCOA/ ePRO) Joanne Hayward-
    Thomas De Smet (ECG) Sewell
    Tina Peerenboom (Biomarkers
    (Pulm) Lab)

    Annette Saiqa Tabasum


    Schneidereit-Hanke Rosa Altarcheh (Central Lab)
    (Chiltern Xifro (IWRS)
    CTS)

    5 | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |


    GEOGRAPHICAL DISTRIBUTION

    8 countries involved (for a total of 160 sites)

    Bulgaria
    Germany
    Hungary
    Poland
    Romania
    Russia
    UK
    Ukraine

    6 | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |


    REGULATORY ACTIVITIES

    Competent Ethics Commitees


    Authorities

    Planned approval Planned approval


    Actual approval Actual approval

    Initial SA Initial SA

    UK 05 Sep 16 22 Nov 16 14 Oct 16 NA

    Germany 04 Oct 16 27 Oct 16 19 Oct 16 24 Nov 16

    Hungary 24 Oct 16 07 Jan 17 24 Oct 16 07 Jan 17

    SA: Substantial amendment

    7 | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |


    REGULATORY ACTIVITIES (cont’d)

    Competent
    Country Ethics Commitees
    Authorities
    Planned approval Planned approval
    Actual approval Actual approval

    Bulgaria 2 Dec 16 21 Nov 16

    Poland 19 Dec 16 11 Oct 16

    Romania 14 Mar 17 16 Jan 17

    Russia 22 Dec 16 22 Dec 16

    Ukraine 30 Dec 16 From Nov 16 (LEC)

    8 | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |


    TIMELINES

    2016 2017 2018


    May Dec Jul Feb Oct

    Set up
    FPFV LPFV

    Recruitment LPLV

    Treatment CSR

    Close out
    ACTIVITIES PLANNED

    First Patient In End Dec 2016

    Last Patient in Mid July 2017

    Last patient Last Visit Mid Feb 2018

    Clinical Study Report July 2018

    9 | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |


    RECRUITMENT EXPECTATIONS

    Screened Randomised
    Countries PIONEER Sites
    Patients Patients

    Bulgaria 16 139 80
    Germany 5 36 15
    Hungary 13 98 61
    Poland 23 234 149
    Romania 19 77 57
    Russia 41 370 269
    UK 1 4 1
    Ukraine 42 616 470
    Total 160 1574 1102

    10 | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |


    RECRUITMENT PLAN

    Cumulative Planned Screened (Blue) & Randomised (Red)


    1800

    1600

    1400

    1200

    1000

    800

    600

    400

    200

    0
    01-Dec-16 01-Jan-17 01-Feb-17 01-Mar-17 01-Apr-17 01-May-17 01-Jun-17 01-Jul-17

    SCREEN RAND

    11 | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |


    PIONEER

     First Patients screened by end December 2016


     Site Initiation Visits have started beginning of December
    for sites where Ethics and Regulatory Approvals have been obtained and final Financial
    Agreements signed

     1574 patients screened by mid July 2017

    12 | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |


    PIONEER

    THANK YOU

    GOOD LUCK FOR THE


    RECRUITMENT
    13 | Regulatory_Timelines | C. Francisco | 7-8 Dec 2016 | IM Pioneer |

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