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Clinical Operations
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Our goal as a Clinical Research Organization is to play a pivotal role in the drug development process and Help Lifesavers Save Lives. The clinical operations team is backed by a cumulative experience of over two decades across Phase 1 to Phase 4 clinical studies and scientific expertise in niche therapeutic areas and indications. We work with our client as a true strategic partner, help them optimize clinical trial design and guide them through the regulatory pathways through innovative approaches.   

Our integrated team’s approach, ‘One Data One Team’ endeavours to offer strong subject recruitment and retention strategies, quicker start up timelines, and efficient project management proficiency focused towards increased site productivity and resulting data quality.  Strong and trustworthy governance at SIRO, ensures a smooth study conduct experience and help our clients with solutions to their therapeutic, regulatory, and operational challenges.

Differentiators

Pan India Reach

We have access to 1000+ hospital with registered Ethics committee and 2000+ investigators across various therapeutic areas.

Sites include major private and government hospital in metro as well as rural setup.

Singular Point of Contact

In age of hyper communication, we keep it simple. Our clients do not have to communicate with multiple stakeholders.

Each trial is assigned a project manager who keeps your trial on track while supervising the operational and vendor activity along with real-time updates on progress of the study.

Rapid start-up time

With several years of experience of working with highly reputed medical institutions in India, SIRO can provide expedited and realistic start-up timeline for your study.

A synchronized approach from protocol writing to regulatory approval; the same team allocated to execution of project ensures continuity in delivery.

Regional Presence

Understanding local nuisances is a key to the success of a study at site. SIRO has deployed regional clinical research associates across major cities in India.

This regional staff can provide immediate support to investigators and expedite study conduct.

Technology Integration

Our integrated technology solution includes: Clinical Trial Management System (CTMS), Electronic data capturing, E-diary for patients, IWRS; in a common platform which ensures access to real time intelligence for our sponsors.

Rescue service provider

Customizable solution for stalled projects to ensure its timely completion, our experienced team has often provided practical solutions rescuing some of the pivotal clinical trials/programs for sponsors across the globe.

Case Studies

CLINICAL OPERATIONS CASE STUDY 1

Successful conduction of a BA/BE drug trial having a challenging inclusion/exclusion criteria, in Breast Cancer patients of a Metastatic setting.

CLINICAL OPERATIONS CASE STUDY 2

A challenging Device Study in Oncology using a complex drug delivery technique.

CLINICAL OPERATIONS CASE STUDY 3

Unhappy with the deliverables of the global CRO, a client requested SIRO to manage the study mid-way from LPI to LPO.

CLINICAL OPERATIONS CASE STUDY 4

Management of a complex oncology trial involving monoclonoal antibody coupled with radioactive isotope having a half life of only 5 days, due to which the finished product had to be first manufactured in India and then immediately administered to Glioblastoma patients.

CLINICAL OPERATIONS CASE STUDY 5

Study involving diabetes patients who were fasting for more than 12 hours per day and were not flexible with taking short meals/ medicines/ blood draw during Ramadan.