Busymode

Our Services:

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.

Core Service:

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
Protocol writing
Developing case report forms and consent forms
Logistics
Patient instruction manuals, record card

Identification and facilitate start up of participating institution -

Site evaluation
Select investigator
Regulatory documents submission when required
Personnel training
Study initiation

Monitoring progress and auditing -

Monitoring services
Generation of monitoring plan
Monitoring visits and reports
Source document data verification
Regulatory document
Protocol amendments

Data management

Data management planning
Database design and development
Data entry

Statistical evaluation-

Biostatistics consultation
Trial design and protocol development
Sample size estimation
Randomization
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.