Meet Mene Research At: Partnerships with CROs

April 29 - April 30, 2009 Rosen Shingle Creek Hotel Orlando, FL
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Mene Research had a Regulatory inspection by
During the month of January 2009, Mene Clinal
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the importance of the ECs
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  Our mission is to deliver best value to the benefit of patients,clients,employees and government through
innovation,trust,speed,quality,global orientation,sound business management and dedication to excellent service.
 

 

 

 

 

 

    MENE Research is established in 2002 and located in Science-park of Gebze Organized Industrial Zone (GOSB), which is recognized as one of the most developed and modern organized industrial zone in Turkey and planned to be a new company relying on the proven skills of its founder and her colleagues  to take the advantage of the growing potential of clinical research activities. 

    Our mission, is to deliver best value to the benefit of patients, clients, employees and government through innovation, trust, speed, quality, global orientation, sound business management and dedication to excellent service. 

    Our vision, is to primarily provide clinical monitoring and supporting services and to design, develop and market new patented software products in the clinical research field. 
    MENE Research is established in 2003 and located in Science-park of Gebze Organized Industrial Zone (GOSB), which is recognized as one of the most developed and modern organized industrial zone in Turkey and planned to be a new company relying on the proven skills of its founder and her colleagues  to take the advantage of the growing potential of clinical research activities. 



    REPUBLIC OF TURKEY

      Population    72 million 
      Capital City   Ankara (3.6 million) 
      Currency    New Turkish Lira (NTL) 
      Languages   Turkish 
      Latitude (Capital City)   39° 55' N 
      Longitude (Capital City)   32° 50' E 
      Coastline    7,200 km  
      Area (map projection)    779,452 km2 
      Time Zone   (GMT +2) 
      7 Geographic regions   

    Qualified work-force
    Turkey offers investors competitive labor costs with a workforce of over 24.7 million young, talented, motivated and skilled people. The Turkish cultures’ devotion to work, flexible working hours and a low absenteeism rate has allowed Turkey to reach remarkable productivitylevels.  

    Customs
    Turkey joined the Customs Union with the EU on January 1st, 1996 and has amended its customs code and legislation in line with those of the EU Customs Code. Since then Turkish customs laws have been harmonized with those of EU customs practices. 

    Transport



    NUMBER OF AIRPORTS:   52 (20 international)
    Source: Turkish Ministry of Transport - 2007

    Health
    # of Hospital: 1.1191
    # of Hospital beds: 196.000

    Clinical Research Regulation
    Clinical researches were conducted in Turkey since 1900s and the first local regulations were dated 1928. Over the time, the local regulations have been adopted and updated according to international needs and requirements. Recently since 1993, investigators were following the local regulation which was in line with ICH-GCP. As of 23 December 2008, Turkey came one step closer to Europe with the new Regulation Regarding Clinical Trials, totally in parallel with the European Directives 2001/20/EC and 2005/28/EC.  In March 2010, regulation updated in Turkey.


    Import licence approval 1 week

    Single application

    GCP/ Experience
    1) LEC standardisation trainings (conducted by MoH)
    2) GCP courses: ~1500 doctors certified
    3) GCP courses planned for study nurse in 2008 ( GCP certification will be required for investigators with the new regulation in  June 2008)

    Audit/ Inspection experience
    1) 
    5 FDA inspections
    2) 1 EMEA inspection
    3) 1 Bfarm inspection
    4) Many sponsor audits

    Budget/ Contracts
    1) Tripartite contract ( Hospital- Inv- Sponsor)
    2) Approx Gross payment to the Investigator (%) 42 from the study budget
    3) Hospitals accept the sponsor contract templates if applicable
    4) Some hospitals are insist on using their templates
    5) Contracting procedure takes approx 4-8 weeks

    Signed contract is not mandatory for regulatory submission 

    In conclusion
    Turkey offers good opportunities with regard to the high number of enthusiastic physicians moreover; higher availability of treatment-naïve patients interested in participating in clinical trials...


    To provide service compatible with national and international standards with our experience specific to the sector in all activities related to clinical researches that we conduct by respecting to ethical, privacy and impartiality principles

    To ensure the highest satisfaction of the customers and to protect the benefits of the customers and that of the country and primarily that of volunteers in the highest level, to study with reliable companion, continuity and objective assessment


    To terminate the given service in the committed time by working in result-focused manner

    To determine our fundament philosophy as the continuous improvement in all fields and as the continuous training for the development of the staff and as the collaboration with the educational institutions and not to confine to protect or current status

    To work with team apprehension, speed, reliability, accuracy, quality and global point of view are our main policies

    MENE RESEARCH administration commits that these policies will be conveyed to all staff and that will ensure the comprehension of these policies. These policies constitute a framework for the objectives and they are consistently reviewed.

     

 
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