Ethic Medical Research Ltd. » Our Services https://www.ethic-cro.com/en Mon, 07 Mar 2011 20:32:26 +0000 en hourly 1 http://wordpress.org/?v=3.0.3 Project Management & Clinical Monitoring https://www.ethic-cro.com/en/project-management-and-clinical-monitoring https://www.ethic-cro.com/en/project-management-and-clinical-monitoring#comments Tue, 01 Mar 2011 20:10:04 +0000 admin http://www.ethic-cro.com/en/?p=9 ETHIC Medical Research Ltd. with qualified and experienced staffs conduct project management and phase studies based on Local regulations and ICH GCP guideline. Our dedicated clinical teams of skilled professionals provide consistent and effective monitoring and interaction with study sites.

We provide comprehensive feasibility assessments and analysis to help our clients determine the most cost effective and timely operational strategies for clinical trial or program execution. ETHIC study monitors are specifically trained in the complexities of the multidisciplinary trial environment.
Their services include;

  • Monitoring study progress
  • Source document reviewing and verification
  • Confirming patient eligibility
  • Tracking patient compliance
  • Maintaining various databases
  • Managing study supply inventories
  • Reporting adverse events
  • Monitoring regulatory compliance
  • Maintaining regulatory documentation
  • Site monitoring visits provide to opportunity to discuss recruitment strategies and potential problems and compile direct feedback on performance
]]> https://www.ethic-cro.com/en/project-management-and-clinical-monitoring/feed 0 Clinical Trials Regulatory Support https://www.ethic-cro.com/en/clinical-trials-regulatory-support https://www.ethic-cro.com/en/clinical-trials-regulatory-support#comments Tue, 01 Mar 2011 19:50:10 +0000 admin http://www.ethic-cro.com/en/?p=12 ETHIC Medical Research Ltd. guides our clients through the complexities of regulatory affairs with effective assessment and strategies to ensure a project progress quickly and efficiently.
Submission timelines and obtained approval letter based on local regulations in Turkey is determine after provide all necessary documents form client. ETHIC Medical Research Ltd. provide to client possible submission date and approval date.

  • Final approval to carry out clinical research in The Ministry of Health,
  • Approval in the regional committee for ethics,
  • Obtaining permission of customs committee to import/export investigative product (IP), biological specimens and medical equipment,
  • Translation services, including back translation.
]]> https://www.ethic-cro.com/en/clinical-trials-regulatory-support/feed 0 Study Coordinator https://www.ethic-cro.com/en/study-coordinator https://www.ethic-cro.com/en/study-coordinator#comments Tue, 01 Mar 2011 19:49:43 +0000 admin http://www.ethic-cro.com/en/?p=18 Ethic Medical Research Ltd. provides qualified and experience study coordinator to study site according to study design. Study coordinators perform high quality data collection, data capture and data entries based on study protocol and international/national regulations. Our coordinators have been trained ICH GCP and local regulations. We work with qualified and experienced study coordinator to provide our client with quality and cost effective site coordination in adherence to ICH GCP and local regulations. Also study coordinator performed responsibilities related study protocol but not limited with listed below.
Responsibilities;

1- Knowledge of ICH, GCP and Local Regulations.

2. Identifies, develops and reviews assessment tools, data collection tools and methods to collect data in consultation with the Principal Investigator.

3. Provides data entry and monitors the quality of the database

4. Assists the PI in promoting the project and its objectives to the clinical team and to external community partners.

5. Represents project at local, national and international meetings.

6. Ability to understand protocol requirements and communicate those requirements to clinical/laboratory staff.

7. Participate in the early planning phases of clinical study by providing assistance in the preparation of study proposal timelines, scheduling and other study requirements as appropriate.

8. Evaluate, coordinate, and ensure the completion of all protocol related documents

9. Assure resolution of all Quality control discrepancies related to data and research documents.

10. Coordinate with Sponsor Company to ensure timely submission of regulatory documents to EC (if necessary) and CRF completion.

11. Assure prompt AE/SAE reporting

12. Perform all duties and responsibilities in accordance with CFR, GCP/ICH and other applicable guidelines.

13. Assist to PI site regulatory file for completeness and accuracy on an on-going basis.

14. Strong communication skills and problem solving skills

15. Participate in trainings

]]> https://www.ethic-cro.com/en/study-coordinator/feed 0 Contract Employee https://www.ethic-cro.com/en/contract-employee https://www.ethic-cro.com/en/contract-employee#comments Tue, 01 Mar 2011 19:47:13 +0000 admin http://www.ethic-cro.com/en/?p=14 ETHIC Medical Research Ltd. offers contact to hire staffing services to determine if an employee is the right fit for your company by observing the employee on the job. After the contract period is complete, the option is avaliable to hire the employee on a permanent basis. We provide trained workforce on demand . We periodically also perform in house training to employees.

]]> https://www.ethic-cro.com/en/contract-employee/feed 0 Study Documents https://www.ethic-cro.com/en/study-documents https://www.ethic-cro.com/en/study-documents#comments Tue, 01 Mar 2011 19:34:36 +0000 admin http://www.ethic-cro.com/en/?p=6 ETHIC Medical Research Ltd. provides the study documents according to local regulations and ICH GCP requirements. Study documents include as mentioned below but not limited. ETHIC Medical Research Ltd. can be provides study specific documents as well.

  • Signed and dated protocol signature page,
  • FDA form 1572,
  • Curriculum Vitae (signed and dated within 2 years),
  • Medical license of investigators,
  • Submission to The Ministry of Health and provide approval letter,
  • Signed and dated the confidentiality agreement,
  • Contract negotiations(two way/three way),
  • Ethics Committee Member list,
  • Financial Disclosure Form.
]]> https://www.ethic-cro.com/en/study-documents/feed 0 Data Entry Management https://www.ethic-cro.com/en/data-entry-management https://www.ethic-cro.com/en/data-entry-management#comments Tue, 01 Mar 2011 18:31:02 +0000 admin http://www.ethic-cro.com/en/?p=1 - Case Report Form
Case report form can be created as Turkish or English language according to our clients preference. Our service is price according to level of job, deadline and paper quality.

- Software developer for Electronic Data Capture
Software developer is graded according to study phase. ETHIC Medical Research Ltd. has software the phase III, phase IV, bioequivalent and observational studies. ETHIC provides to clients private software developer as well.

- Data Entry
ETHIC Medical Research Ltd. provides temporary staffs to client for data entry.

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