Clinical Data Management

Implementing Cutting-Edge Technology to Deliver High Quality Data
Managing Clinical Data in the existing complex regulatory scenario is the most challenging task. With R&D costs spiraling upwards, patents expiring on many molecules and stringent FDA requirements for new drug approval, it is imperative that there is need to reduce time-to-market and minimize costs.

At SIRO, we understand clinical data management challenges. We offer end-to-end clinical data management solutions integrating technology and clinical data expertise, supported by a robust quality management framework to deliver high quality data. From clinical operations to drug approval, we offer solutions every step of the way.

Our Services
SIRO offers end-to-end clinical data management services which include:
  • pCRF/eCRF Design
  • Database Design and Programming
  • Database Testing and UAT
  • Data Migration
  • Data Loading
  • Scanning and Indexing
  • Data Entry
  • Data Review
  • Laboratory Data Management
  • SAE Reconciliation
  • Medical Dictionary Coding
  • Quality Control Activities
  • Database Lock
  • Archival

Why Choose SIRO?
Our team of professionals believes in leveraging the in-house experience with oversight from subject matter experts to provide the best-in-class services. There's so much more to us. Here's why you choose SIRO:

Experienced Individuals
We have an experienced resource pool with average 5+ years and life science background. Medical doctors and pharmacy graduates execute dictionary coding and medical review activities ensuring high quality data. The team has exposure to a diverse range of therapeutic areas, and each project is led by Clinical Data Management Project Managers who apply efficient and effective project management principles to manage time, cost and quality.

Customer Focus and Flexibility
We are highly sensitive and responsive to client needs and focus on delivering cost-effective solutions. We have a 24x7 help desk support to investigators / site staff. We have implemented a robust metric-driven approach to reduce overall trial timelines and ensure quality data. We ensure committed Executive Management oversight through Steering Committee forums to ensure achievement of client objectives.

Data Trending and Comprehensive Data Review
We understand that data cannot be looked at in a 'piece-meal' fashion, and we drive comprehensive data review across the data validation team. We also support our sponsors by providing them with data trending reports that actually help them monitor the performance of the sites and the trial. We also provide the scientific writing services necessary to articulate the findings present in your data.

Business Models
Our services are available as stand-alone clinical data management services as well as part of comprehensive full-scope clinical trial management programs. We are flexible to provide data management services with quick ramp-up capability for various service delivery models like:
  • Individual project outsourcing models
  • Dedicated FTE business models
  • FSP business models

For more information email us at : global.dm@siroclinpharm.com.

Partnering for Success With Oracle to enhance global EDC trials
Our IT capabilities in the region are second to none. By deploying Oracle Health Sciences InForm, we have upgraded our technology platforms to global standards. Combined with our expertise in clinical development, we can now offer our clients a very effective and seamless user experience.

The Technology Advantage
We offer flexibility, scalability and real-time access to trial data to streamline and accelerate large and complex international trials.

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