Experts of practising medical fraternity would focus trials in the prevention of disease, epidemiological study of the preventable diseases and improving quality of life in chronic disease.
Medclin Research would ensure stringent monitoring systems to provide patient safety, data integrity and at the same time look into the speed of the recruitment and completion of the trial.
FUNCTIONAL AREAS and OPERATING PROCEDURE
The advisory board, panel of investigators and well trained clinical monitors and data safety monitors, data analyst would help through the process of protocol designing till clinical report development. The following services would be provided by a team of experts:
Protocol designing and documentation development -
Consult study design
Developing case report forms and consent forms
Patient instruction manuals, record card
Identification and facilitate start up of participating institution -
Regulatory documents submission when required
Monitoring progress and auditing -
Generation of monitoring plan
Monitoring visits and reports
Source document data verification
Data management planning
Database design and development
Statistical evaluation -
Trial design and protocol development
Sample size estimation
Statistical analysis and report
Clinical report -
Clinical and statistical integrated report
Review of the trial- efficacy, safety, tolerability, compliance and acceptability and effectiveness
Regulatory submission if required
Scientific publication -
Facilitate journal publication when necessary
Medclin Research and SMSRC would form a strategic alliance which would help to have a nationwide coverage to carry out clinical trials in an increasingly efficient manner to ensure high quality, cost-effectiveness and speed with personalized service.
If a sponsor desires site management service we can offer such a service at selected sites, using central ethics committee and to ease the communication between all parties involved in a clinical trial. Hence, the success of our service vests on determining the current market landscape regarding the use of each service; understanding customers’ needs and wants; understanding perceptions regarding our service capabilities versus other providers and obtaining reactions to each service concept.