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Clinical Drug Development Solutions

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Data Management

In areas of clinical trial, research and drug development, collection, application and assimilation of data is crucial. The SIRO data management team of experienced members with exposure to numerous cases understands the special commitment and dedication it takes to contribute and make a difference to client needs.

  • Dual edge of data management technology & clinical expertise
  • Diverse therapeutic area & application expertise
  • Consistent data management innovations
  • Demand specific solutions

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 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 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

Our global data management team is headed by highly experienced professionals of this 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 ongoing innovation program, wherein we invite innovations from the team and ensure the implementation of ideas that contribute to process efficiencies and break-through methodology. 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 help 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.

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