Clinical Operations and Project Management

Clinical Operations

As a trusted CRO, SIRO excels in providing comprehensive clinical operations services tailored to the dynamic pharmaceutical and biotech landscape. We offer end-to-end solutions for all aspects of clinical trial management, ensuring seamless execution from study inception to CSR submission. Our experienced team of CRAs and project managers oversees clinical study operations across all phases and diverse therapeutic areas. We specialize in optimizing trial design, implementing cutting-edge methodologies, and navigating regulatory pathways for successful client outcomes.

Phase 1 to 4 Studies

Provide expertise in setting up and delivering end to end solution for early phase, pivotal as well as post marketing phase 4 trials for various pharmaceutical and biotech sponsors across the globe.

Extensive clinical trial network and experienced team to assist sponsors with strategy planning and most efficient route of success in conducting clinical trials.

Our project management team adheres to the highest standards of operational excellence and ‘established industry best practices’ to ensure high quality and on-time deliverables.

The Clinical monitoring team trained extensively in local regulations, study protocols and therapeutic areas and guided by dedicated medical monitors forms the core delivery team.

With state of the art Clinical Trial Management System and systematic filing & correct documentation processes maintained via paper or e-TMF, a well-established documentation system is one of the foundations of the functioning of clinical operations.

SIRO offers a robust 21 CFR Part 11 compliant clinical trial management system to support document tracking at global, country and site level.

Bioavailability / Bioequivalence

Bioresearch studies on patients has been SIRO’s forte for two decades.

Understanding of nuances of pharmacokinetic studies, preferred logistics and bio analytical provides an advantage in managing of bioavailability/bioequivalence studies.

SIRO monitors are trained for onsite real-time monitoring of complex dosing and pharmacokinetic procedures assuring you compliance, credible data and reliable results.

Appointment QC coordinators and PK experienced phlebotomist aid in accuracy of the study.

FMCG

Experienced talent pool provides end-to-end solution customized as per product requirement in various FMCG domains.

Cater to various domains of Personal care – Skin and spot lightening care, Hygiene, Oral care; Food and Nutrition – Food supplements, Nutraceuticals, Herbal Supplements (compliant to AYUSH guidelines), Devices – air purifiers to name a few.

The team is well versed in building product development strategies– Claims Selection, Validation, Claims Substantiation; conducting Clinical Studies – evidence generation, report writing and managing Publication.

Being the oldest Indian CRO, all the processes are compliant to the ICH-GCP guidelines and local regulatory requirements, making the data credible to be used and submitted to all the geographies throughout the world.

Rescue Studies

With an accomplished team of experts, including study managers, CRAs, safety scientists, regulatory specialists, medical monitors, and statisticians, and a strong track record of success, SIRO is well positioned to provide rescue services to bring failing studies back on-track. With availability of real-time data, the project management team focuses on issues and bottlenecks affecting the clinical study. A specialised team can identify the issues and offer productive and proactive solutions.

Our accommodating and knowledgeable teams and systems integrate into existing study and change only those aspects which impede the study’s progress.

Successes in rescue studies result from corrective action plans custom-designed to fit the needs of individual studies – a combination of protocol revisions, additions of sites, elimination of poor performing sites/investigators, streamlining communication flow, and direct hands-on management at the site level.

Real World Evidence Studies

Real world evidence (RWE) is clinical information gathering on usage of marketed product, potential benefits, risks, compliance or just structured information on disease condition of interest.

SIRO has successfully conducted a number of RWE observational studies (prospective and/or retrospective).

These type of studies supplement existing clinical information on usage of study product in broad routine clinical practice which can be helpful to support efficacy, safety claims on study product.

Inspection Preparedness

Expertise in preparing your site and investigators for regulatory inspection.

Experience in conducting several US FDA, EMEA and DCGI inspections and no critical findings.

SIRO has pre-identified, trained SWAT teams always ready to take-on one or multiple sites for inspection readiness.

Over the years more than 5 of India’s top pharmaceutical companies have consciously chosen SIRO as their key partner for this service.

Fixed Dose Combination (FDC) Studies

Regulatory efforts towards rationalization and need for clinical data for FDCs has posed a unique challenge to Indian pharmaceutical industry.

A robust and customized solution especially focussing on the needs of small and mid-sized pharma companies.

The solution offers designing of scientifically validated, short and simplistic trials which would be readily acceptable to regulatory and Ethics committees of sites.

The studies are conducted through SIRO’s select partner sites spread across India which have high and predictable set-up timelines, recruitment and data retrieval.