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| Data Management |
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» Dual Edge of Data Management Technology & Clinical Expertise
» Diverse Therapeutic Area & Application expertise
» Consistent Data Management Innovations
» Demand Specific Solutions
In areas of clinical trial, research and drug development, collection, application and assimilation of Data is crucial. The
SIRO Data Management team of about 150 experienced members with exposure to over 200 cases understands the special commitment
and dedication it takes to contribute and make a difference to client needs.
At SIRO, we have worked with a wide range of clients - including local and larger-scale global sponsors. Irrespective of
client history, we offer world-class Data Management services, sensitive and responsive to your needs. Our team has a
cumulative experience of working on a diverse range of therapeutic areas and trials - EDC/RDC, paper trials and so on - and
also business models including individual projects, outsourcing model, the FTE model and the FSP model.
The team has also worked effectively on and mastered sponsor's systems. When we work for a client, we don't just believe in understanding their systems, we contribute to them, and we make a difference...
Key Benefits of SIRO
Customer Focus and Flexibility
A team of about 150 experienced data management professionals working with global clients, across a vast range of therapeutic indications. We have worked across different business models, including the individual project outsourcing model, the FTE model and the FSP model. We are highly sensitive and responsive to client needs, whether big or small and focus on delivering cost-effective solutions.
Key Experienced Individuals
The team is led by the first CCDM (Certified Clinical Data Manager) from India of the Society of Clinical Data Management, USA, with over twelve years of experience in the industry. We believe that the role of the DM Project Manager has changed to that of a strategist, who can play a key role in driving the progress of the trial and hence focus on providing in-depth training on DM methodology. Thus, we have a unique service offering in the field of data management, which makes us stand apart from other ITES and DM service providers.
DM Innovations and Lean Six Sigma
We believe in making the difference. And we achieve the same by having an-going innovation program, wherein we invite innovations from the team and ensure the implementation of ideas that contribute to process efficiencies and break-through methodology. These processes are our value-add to our customer. We also have trained Black/Green belts on the team and we believe in thinking 'lean' and implementing 'poka-yoke'.
Data Trending and CDR
We understand that data cannot be looked at in a 'piece-meal' fashion and we drive CDR across the data validation team. We also support our sponsors by providing them with data trending reports that actually helps them monitor the performance of the site and the study.
Services Offered
Coding
We have a team of highly experienced coders, with vast expertise in different coding dictionaries and have even provided training on performing coding to sponsors.
CRF Designing
We also have expertise in CRF designing and have designed CRFs in Type 2 Diabetes Mellitus, Cryptococcal Meningitis, Visceral Leishmaniasis (Kala-Azar), Psoriasis and Tetanus, breast cancer, overactive bladder, etc.
Medical Review
We have a team of medically qualified professionals, capable of performing medical review and effectively validating clinical data.
Case study
The SIRO DM team had to manage the data for two twin studies of 576 patients each, for US FDA submission. Approximately 28,000
pages had to be processed over 10 months. However, SIRO received almost 13000 pages (almost 40%) in the last month alone. All
the pages and over 60% of the queries were effectively processed by the team and timelines for database lock were effectively
met.
This speaks of effective risk management and contingency planning.
A quote of appreciation from one of our clients:
"One of the reasons that I recommend SIRO is that their DM project managers have both the technical competence and the medical judgment when they handle clinical data. I cannot find this when I work with other CROs, data managements companies and other ITES.
To me I think this is something that you should be proud of"
-Principal Scientist
Top 5 Global Pharma.
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