1.      Project Management

a.   Protocol and CRF Design                                                                                                      

b.   Site& Investigator  selection and management                                                             

c.   Regulatory consulting on protocol design and implementation                                       

d.   Bio-Statistical Services

1.      Biostatistics

2.      Data  Management

3.      Statistical Analysis

4.      Statistical Report Writing

e.   Establishment and maintenance of site regulatory files                                                    

f.   Clinical Trial Monitoring 

1.      Adherence to protocol-specific monitoring guidelines

2.      Assurance of compliance to protocol and GCP s

3.      Regular review of study binders

4.      Case Report Form review and retrieval

5.      Study medication tracking and accountability

6.      Adverse experience identification and follow-up

g.    Design and implement subject recruitment strategies                                              

h.   Assurance of the achievement of timeline milestones                                                 

i.    Coordination and oversight of all study-related activities with the sponsor, the study sites, and with all operational and consultative departments within Mene Ltdh.esponsibility for fiscal management of the project budget on behalf of Mene Ltd.and the sponsor.                                                                                                                  

j.    Organization and facilitation of Investigator  Meeting                                             

k.      Market Research

 Collecting and reviewing data about Turkish pharmaceutical market and creating tailor made reports

                2.      Training, Education for Sponsor/Investigator and Clinical Research support

            a.   GCP/ICH training

            b.   Conducting meeting about study protocol and laboratory procedures for the site research groups

3.      Regulatory Affairs and Operations

            a.      Consulting services on registration process

            b.      Registration dossier preparing

            c.      Submission of the registration file preparing according to Local regulations

            d.      Follow-up & Lobbying activities

            e.      Modifying product characteristics Type I &II activities

            f.      Upon request prepare of short product of charecteristics

4.      Technical Translation

            a.      Turkish-English

            b.      English-Turkish

5.      Medical Writing

            a.      Integrated clinical & statistical reports

            b.      Advisory committee presentations

            c.      Literature supply

            d.      Journal manuscripts

             e.      Abstracts & posters

            f.      Computer based  presentations

6.      Data entry and management

7.      Strategic Consultancy