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Turkey: How to select a CRO and establish a long-term relationship?. Edibe Taylan Medical & Public Affairs Director Sanofi-aventis,Turkey Vienna Conference on “Optimizing Clinical Trials in CEE-CIS Region” February 14th, 2008. Speech headlines.

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Turkey how to select a cro and establish a long term relationship l.jpg

Turkey: How to select a CRO and establish a long-term relationship?

Edibe Taylan

Medical & Public Affairs Director

Sanofi-aventis,Turkey

Vienna Conference on “Optimizing Clinical Trials in CEE-CIS Region” February 14th, 2008


Speech headlines l.jpg
Speech headlines relationship?

  • Background information on Clinical Research in Turkey

  • Outsourcing strategies

  • Turkish experience: Effective CRO management

  • Relationships with CROs/ one-time award vs long-term partnerships

  • A Best Practice from sanofi-aventis Turkey

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Clinical research environment in turkey l.jpg
Clinical research environment in Turkey relationship?

  • Increasing experience & participation in new clinical trials

  • Total investment by industry 15 m€1

  • Total No of Clinical studies 316 2

  • Number of CROs 9 3

    • 4 local, 5 international

  • No of Clinical Research personnel ~200

  • 2 key associations in the area

    • Turkish Association of Research Based Companies

    • Clinical Research Association

1Turkish Association of Research Based Companies survey_2006

2 www.clinicaltrials.gov

3 IKU Journal volume 16

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Number of clinical studies in turkey by sponsor l.jpg
Number of clinical studies in Turkey relationship?By sponsor

316

www.clinicaltrials.gov

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Number of clinical studies in turkey top 10 pharmaceutical company l.jpg
Number of clinical studies in Turkey relationship?Top 10 Pharmaceutical Company

www.clinicaltrials.gov

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Slide6 l.jpg

There is a huge potential for clinical research in Turkey when compared to the population of other countries

www.clinicaltrials.gov- January 15th, 2008

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Turkey has a competitive advantage in clinical research l.jpg
Turkey has a competitive advantage in clinical research when compared to the population of other countries

  • Patient population

    • sufficient

    • esp naive patients

  • Legislation is present for a long time

    • 1993 Regulations on Pharmaceutical Research

    • 1995 Guideline on Good Clinical Practice

    • 2008 Guideline on Observational Studies

  • Investigators

    • high number

    • trained on GCP

    • experienced in multinational/multicenter trials

  • Investigative sites

    • can produce qualified data

    • are reputable internationally

    • have technical infrastructure

    • have local ethical committees

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Sanofi aventis is the leading company in turkey with l.jpg
Sanofi-aventis is the leading company in Turkey with… when compared to the population of other countries

  • 60 projects are ongoing

    • in 250 clinical research sites

  • Total 40 s-a employee in clinical research both R&D team and affiliate team

  • Additional 13 FTE outsourced to CROs

  • Experienced in CRO management

    • Worked with 7 CROs

    • Partnership with only 1 CRO (namely Monitor)

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Outsourcing in clinical research is a unique opportunity if the company l.jpg
Outsourcing in clinical research is a unique opportunity if the company…

  • has limited number of internal headcount

  • has limited expertise in some therapeutical areas

  • needs flexibility in providing headcount in a short time

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Thus cros are important players of the game by their services l.jpg
…thus CROs are important players of the game by their services

  • Clinical Trial Management

  • Statistical planning/Analysis

  • Protocol,CRF etc design and writing

  • Final Study Report

  • Training partnership

  • Investigator Meeting organisation

  • Staff/Resource management

    Partial or full support in each item

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


S a turkey cro management phases l.jpg

A new study to be services

outsourced

1. CRO selection

2. Contract management

3. Study conduct

4. Close out

S-a Turkey :CRO management phases

5. CRO evaluation

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


S a turkey cro selection steps l.jpg

Calculate the resource needs services

Identify CROs for request for proposal

Collect proposals (purchasing department)

Negotiate the total cost (purchasing department)

Send the final cost proposal to clinical research department

Select CRO & document the reason (Clinical Operations)

Inform CROs of the outcome (purchasing department)

S-a Turkey: CRO selection steps

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


S a turkey cro segmentation targetting decision making flow l.jpg

Meeting with CRO services

(presentation of the organization)

Is the experience adequate?

No

Reevaluate the CRO next year during annual planning

Yes

Yes

Yes

Yes

Start Request for proposal (RFP)

Is the price within acceptable range (after negotiations)?

No

Reevaluate the CRO next year during annual planning

Start working with a non-GCP study

No

Position as last option to work with a non-GCP study

Is performance satisfactory?

Continue working with a non-GCP study

Organize system audit to CRO

Continue working with a non-GCP study

No

Are the system audit results satisfactory?

Consider organizing another system audit after 1 year

Outsource a GCP study

S-a Turkey: CRO Segmentation & Targetting decision making flow

Repeat

system audit

every 3 years

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


S a turkey cro management l.jpg

Study conducted services

CRO selected

End of projects

Co-monitoring visits by s-a for CRO performance evalutions

Closing

meeting

Weekly reports sent by CRO

  • organise a meeting

  • define tasks to be shared

  • prepare the contract accordingly

  • organise a meeting with Purchasing dept to review and document the performance of the CRO

  • according to the experience position the CRO (segmentation & targetting)

  • conduct regular CRO performance evaluations on site to ensure that the trial is monitored in compliance with the terms agreed upon

    • first immediately after the study initiation,at the close out visit and in between when necessary.

S-a Turkey: CRO management

Kick off

meeting

Training on company

SOPs & protocol

  • nominate people according to the need for the study (CPL,CRA, CPA etc)

  • identify training needs

  • decide monitoring plan

  • define co-visit intervals

  • decide visit reporting

CRO Management

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


A best practice for partnership sanofi aventis turkey monitor cro l.jpg
A Best Practice for partnership : Sanofi-aventis Turkey & Monitor CRO

  • Sanofi-aventis started partnering with Monitor CRO 6 years ago.

  • Relationship established as a long-term partnership instead of one-time award.

  • Partnership sustained through cooperating in different projects.

  • Exponential growth achieved in 6 years for both partners

  • “speed, proactivity, synergy, harmonization, persistence, mission, transparency, empathy, success, trust, experience, friendship, responsibility, accountability, initiative, creativity…” characterizes this partnership.

  • Successful partnership resulted in a ‘’win-win’’ case.

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Relationships with cros one time award vs long term partnerships l.jpg

Study conducted Monitor CRO

CRO selected

End of projects

Kick off

meeting

Training on company

SOPs & protocol

Co-monitoring visits by s-a for CRO Performance Evalutions

Closing

meeting

Weekly reports sent by CRO

Relationships with CROs: one-time award vs long-term partnerships

Continuous feedback on the progress (both +/-)

Quarterly meeting of Heads to evaluate team performance & communication

Interim project management meetings, if there is a problem in patient recruitment

Exchange of human resources in case of need or urgency (recruitment to and from CRO)

Cooperation in diffferent projects

CRO Partnership

CRO Management

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Exponential growth achieved in 6 years for both partners l.jpg

Limited HC & expertise in s-a Monitor CRO

Need for outsourcing

Ambitious goal setting with in advance resource planning

2nd study:

Confirmation of

performance

1st study:

Test

  • Great success achieved!

  • 4th country in patient recruitment among 52

  • 2 successful audit reports

  • 2 sites in top 10 patient recruiting sites among 600 (2 awards)

Basement for

partnership

EXCTRACT- TIMI 25

FLINT- ACT

SYNERGY

Exponential growth achieved in 6 years for both partners

22 projects

ongoing

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Partnership sustained through cooperating in different projects l.jpg
Partnership sustained through cooperating in different projects…

  • General Manager of Monitor CRO is the member of AkademiKA® Steering Committee

    • AkademiKA® is the GCP Training program sponsored by s-a

  • Flexible resource management

    • Career opportunity for CRAs of Monitor CRO in sanofi-aventis

    • Contracted clinical research personnel service provided by Monitor CRO to sanofi-aventis

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


Successful partnership resulted in a win win case l.jpg
Successful partnership resulted in a ‘’win-win’’ case

  • Monitor has become a“full-service” CRO

    • Starting from protocol development to final study report preparation…

  • Sanofi-aventis “is the leading company in clinical research” in Turkey

Edibe Taylan, Vienna Conference on ''Optimizing Clinical Trials in CEE-CIS Region''- 13-14 February 2008


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