SIRO sets up outsourced Clinical Data Management & Programming project for a leading global pharma.
Leverages previous experience to operationalize project in record time.
SIRO Clinpharm, a leading multinational full service CRO announced today the operationalization of a new offshore
project for Clinical Data Management (CDM) and Programming in record time. The Project is a dedicated FTE (full
time equivalent) engagement for a NYSE listed global, diversified healthcare company.
The project is fourth in the series of dedicated FTE/FSP engagements for CDM, Biostatistics and Medical writing
that SIRO has operationalized in recent past.
'We are glad that we could use our previous experience and learnings to operationalize the entire project within a
month of the award of contract', said Dr. Nimita Limaye, Vice President, Clinical Data Management and Medical
Writing for SIRO. Explaining the need for rapid project set up she said "the challenging economic conditions have
increased the focus on cost effectiveness and a rapid set up will help our client achieve savings much
SIRO started building up a team within days of the sign-off of the contract. A suitable alliance manager was
identified from SIRO's internal resources and the team was put in place – some resources were sourced internally
and others were recruited. The client team visited and trained the team at SIRO for two - weeks on their
(client's) systems and SOPs. A two-tiered governance model was established to steer the project towards meeting
What helped matters further was that SIRO fared very well in due diligence process performed by third party
auditors. The team now works on Client's systems and SOPs.
While requesting not to be named as per their company policy, the Director, Global Clinical Data management at the
client company said that their lead Auditor (third party) and their Group's representative were very pleased with
all the processes and procedures (at SIRO) that they have looked at. "For me this was expected and I'm glad that
such comments were coming from an independent party." He commented that the CDM team at SIRO is a very experienced
group and seems to work very well with the alliance managers.
Clinical Data Management and biostatistics have been a key focus area at SIRO with the management committing to
several million dollars in ongoing investments in infrastructure, software and human resources to maintain
world-class full-service delivery capabilities. SIRO data management and biostatistics teams are based out of
India and multiple countries in Europe allowing it to offer cost-effective hybrid outsourcing models. Recently Dr.
Nimita was elected as the Vice- Chair of the Prestigious Society for Clinical Data Management (SCDM) in USA.
SIRO Clinpharm Private Limited (SIRO) is among one of the leading global Clinical Research Organizations (CROs),
offering full scope services, conducting clinical trials in the Pharmaceutical, Biotechnology and Medical Devices
sectors in compliance with International Standards. SIRO is one of the first CROs founded in India, which caters
to the needs of pharmaceutical companies across the world. The company has offices in India, USA, Israel and in
Europe at Germany, Romania, Estonia and Greece. SIRO has recently opened offices in Czech Republic & Spain.
About the Company (Client)
The client is a US Headquartered global, diversified healthcare company. It is listed on the NYSE with a global
turnover exceeding 10 billion USD. The company applies a unique combination of expertise in medical devices,
pharmaceuticals and biotechnology to develop and manufacture products that advance patient care worldwide. The
company's products are used in more than 100 countries worldwide to save and sustain the lives of people with
hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions.