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.