Clinical Operations & Clinical Monitoring

Getting your product to the market
As drug pipelines narrow and the number of drugs that make it to the market reduces, it has become increasingly important to invest time and effort in the clinical operations process. The spectrum of work that falls under clinical operations begins with the selection of the right partner who can orchestrate the project just as his own.

At SIRO Clinpharm, we offer end-to-end services to conduct clinical trials for your drug.

Clinical Trial Feasibility Smarter Beginnings to a Successful Study
Feasibility studies are an essential component of study set up, which involves analyzing key regulatory considerations and practical implications of conducting clinical research in a particular geography.

SIRO Clinpharm's extensive clinical network and experience assist you in strategy planning and identifying the most efficient and rapid routes of success in conducting clinical trials. Our experience in conducting clinical study feasibility pans across the globe.

You can be confident of conducting your study with our real-time databases and dedicated resources for identification of new investigators and sites. We also provide the clinical trial supplies necessary to effectively conduct research.

Clinical Project Management Designed to Deliver
Skilled project management is the key to the success of any clinical trial. With an increase in the complexity of clinical trials, importance of effective project management has come to the fore. To attend to various complexities of the trial, you need a team that is not just experienced but is also innovative, flexible and nimble.

At SIRO Clinpharm, we have honed our project management expertise by conducting complex studies in varied therapeutic areas and phases across the globe. Additionally, the location of the project management team has been designed keeping in mind the needs of our clients in the key markets of North America, Europe and Asia.

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. With SOPs designed to ensure smooth communication, collaboration and project ownership, you can be rest assured that your project is in capable hands.

Clinical Monitoring Excellence at the Core
The Clinical Monitoring team is designed to closely work with the project management team in order to ensure that your study is executed precisely. Our team of CRAs, Sr. CRAs and team leaders are familiar with industry best practices and local regulations.

We believe that effective training assures excellence. Therefore, our clinical monitoring team is imparted with exhaustive training in local regulations, study protocols and therapeutic areas.

The geographic distribution of our team lends itself to operational flexibility and efficiency all the while keeping the clients best interests in mind.

Medical Monitoring A Strong Support to Robust Project Management
In the course of your trial, the clinical monitoring group has the support of our dedicated medical monitoring team of experienced professionals across therapeutic areas and phases of the study.

The team ensures detailed clinical study protocol review in correlation with the investigator brochure to identify anticipated challenges during execution of your study. Their anticipatory skills are honed by experience and continuous training programs that help them deliver better results.

Regular training to the project management and clinical monitoring groups generate confident teams on the field. Our medical monitoring team helps the project stay on track and deliver quality. We provide clinical data management that ensures research is done correctly and swiftly to bring the project to market.

SIRO team also provides 24x 7 support to the sites and project team for eligibility review or any protocol query to ensure correct randomization of a subject.

Clinical Documentation
Documentation forms an integral part of Clinical Research Industry bound by stringent rules and regulation.

With systematic filing & correct documentation processes, a well-established documentation system is one of the foundations of the functioning of clinical operations. Keeping this in mind, the Clinical Documentation department was introduced at SIRO. The documentation team is solely dedicated to ensure quality documentation in terms of local regulations, ICH-GCP compliance and standard operating procedures.

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

Phase wise experience
Phase wise experience

For more information email us at bd@siroclinpharm.com or contact us today.