SMO

Clinical trials are essential to deliver new therapies and advance medical knowledge and patient care. A key aspect of a successful clinical trial is the efficient management of clinical sites

Study design: Biometricians help design clinical trials, including determining sample size, randomization methods, and appropriate statistical tests to minimize biases and errors

Site management activities followed before study start-up

Management and review of clinical trial feasibility

Site qualifications – Site selection and pre-study visits

Selection of study investigator

Contract and budget execution

Vendors approval and setup

Site management activities at the time of study start-up

Oversee start-up

Site activation, site initiation visits

Set recruitment expectations

Ensuring training

Site management activities during the enrolment period

Facilitation and review of enrolment

Ensuring regulatory compliance and adherence to the protocol

Management of adverse event reporting

Study document review and query resolution

Data collection

Site management activities during study close-out

Ensuring protocol adherence

Addressing data queries

Ensuring final source data verification of study documents

Managing the collection of final safety data

Review and accountability of all study drug

Assessment and collection of all relevant regulatory documents

Ensure audit readiness

Ensure record retention requirements

Our key to strong collaboration with the sites is ensuring proper site management throughout all phases of a trial. Strong collaboration ensures increased efficiency, consistent communication, adherence to regulations and improved data quality

We focus more on Site selection and feasibility

Development of recruitment criteria

Managing patient recruitment

Inbuilt quality assurance mechanisms

Assurance of Good Clinical Practice (GCP)

Communication with sites

Customizable training based on the needs of the study

Managing of local ethics review processes