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Trial closeout: preparation, attendance and follow-up; forwarding the necessary information of closeout to clients
Regulatory Services
1) Advising the client on regulatory issues
2) Preparation of the regulatory dossier as per the requirements of the regulatory agencies
3) Sharing the regulatory dossier with the client for approval
4) Carrying out regulatory submissions on behalf of clients
5) Following up with the regulatory ECs and CA, and carrying out query clarification and query resolution in consultation with the sponsors
Safety Reporting Services
Pharmacovigilance in trials
In trials managed by our team
1) Subject safety holds the highest priority.
2) Round the clock coverage to receive SAE reporting will be available.
3) Expert medical guidance will also be available if investigators wish to discuss any aspects regarding safety.
4) Adequate process to meet safety reporting obligation towards Turkish regulatory authority are in place and would be customized to sponsors safety-reporting requirements.
Post-marketing pharmacovigilance
Our robust and validated safety management infrastructure can also be used for the management of post marketing authorization safety information (spontaneus adverse event reports).
Service includes:
1) double data entry of received AE reports
2) provision of line listings for PSUR integration
BE/BA/PK studies Monitoring Services
1) Bio-equivalence/Bio-availability studies including: Project management, Study conduct, monitoring, Quality Assurance, Regulatory Affairs activities done directly by us,
2) Volunteer screening, Medical writing, Bio-analytical evaluation, Data Management & Statistics activities conducted with the contracted organization, and studies are conducted by academic personnel, also this unit is certified by Turkish MOH
Study Drug Warehousing-Supply management-Logistics
1) Storage of drugs and devices under ambient, refrigeration and deep freezer conditions backed by round-the-clock temperature logging with online sharing of temperature records.
2) Dispensing of drugs and devices under cold chain and protocol-specific temperature requirements across the country.
3) Quality and process of this services has been audited and certified by Turkish MoH
The warehouse services offered by MENE Research can be either accessed as a part of a study project or be used as an exclusive warehouse service on a standalone basis.
Software Solutions
1) Mene Research designs software solutions to help your team expedite clinical trials.
2) These proven solutions are increase the accuracy and efficiency of conducting clinical trials
Training Services
1) Our team has the expertise to conduct ICH GCP training and workshops for clinical research professionals.
2) Prior to initiating trials, we ensure that all investigators and site personnel are well trained in GCP and any training that is protocol specific.
 
Site Selection & Feasibilities Services
Study Feasibility is conducted to select the best investigators and site
The feasibility for any protocol and therapeutic indication is done across Turkey and the feasibility report is generated which includes:
1) Epidemiological background of the disease – its incidence & prevalence rate.
2) Disease & its Clinical presentation in Turkey.
3) Specific disease mortality and morbidity rate.
Standard of Care in Turkey:
1) Hospital facilities & Medical care in Turkey.
2) Treatment protocol
3) Lab facilities including accredited Central Lab
4) Facilities for Imaging / Radiological investigations.
1) Any exceptional inputs from Investigators on the study protocol along with any challenges in conducting the trial
2) Patient load – indication based
3) Sample CVs of investigators
4) Brief on hospitals
5) Any conflicting factors (internal and external) and/or any competing clinical studies
6) Recruitment strategy
7) Sites with EDC capability.
Based on Study Feasibility report, Site identification/Selection is done based on
1) Patient load
2) Investigator's qualification and interest
3) Hospital infrastructure and resources
4) ICH/GCP trained staff availabilityPapers published bythe Investigator
5) Investigator's and site's previous experience on clinical trial
Monitoring Services
Site Qualification Visit
Site qualification visits to check
1) Hospital infrastructure
2) Resources
3) ICH-GCP trained staff
4) Availability of laboratory/ radiological and imaging facilities
5) EDC facility
Site Initiation Visit
Site initiation visit to confirm
1) Attendance of all team members
2) That the team has received and read the study-related material
3) The PI is prepared to discuss delegation of tasks
The team members are prepared on
1) Reporting of AEs/SAEs
2) Regulations/Guidelines
3) Inclusion/exclusion criteria
4) Check that the procedures and plans for storage, dispensing and return of study medication have been agreed and finalized with the sponsor and pharmacy.
1) Involves a detailed discussion of the type of subject/patient to be recruited, the completion of the CRF and administrative procedures to be followed.
2) In addition, evaluation of the Investigator's understanding of the protocol, his/her obligations during the study and the likely recruitment rate are also be discussed and agreed.
Interim Monitoring Visit
The following issues are addressed at each interim visit as appropriate
1) Informed consent process
2) Source document verification 100%
3) CRF completion
4) Expedient data retrieval and query resolution
5) Drug accountability
6) Check and review of the regulatory binder and its contents
7) Clinical supply inventory
8) SAE reporting
9) Enrolment issues and targets
10) Protocol amendments
11) Significant protocol deviations
12) Acceptability of facilities
13) Personnel changes
14) Updated regulatory documentation
15) Laboratory sample handling
16) Any other issue as deemed important to the conduct of the study
17) The investigator is carrying out the agreed-upon activities and has not delegated them to other previously unspecified staff.
Study Close-Out Visit
The study close-out activities of a clinical research protocol are as important to complete as the initial approval and study start up process. At the completion of the study the Principal Investigator is responsible for ensuring the appropriate close-out activities are completed and the proper institutional offices are notified.
During the Close out of a trial, following issues are addressed
1) Completion of study records
2) Reconciliation and inventory of study supplies
3) Notify institutional regulatory offices
4) Proper record retention of study documentation
Site Coordination Services
1) Patient data scan and short-listing of patients for chronic diseases
2) Help the investigator in screening patients
3) Coordination and management of laboratory samples, courier and follow-ups of lab reports
4) Drug accountability and dispensing at the site
5) IVRS (Interactive Voice Response Services) for patient's randomization in randomized studies
6) Investigational product management, dispensing, temperature monitoring and accountability
7) Preparation, attendance and follow-up of monitoring
8) Completing CRF entry with minimal error
9) Preparation, attendance and follow-up of Audit
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