Data Integrity, a key step in Clinical Research

The historical mishaps and the subsequent efforts aimed towards safe guarding the right and safety of human subjects in clinical trials have helped carve the much needed niche for “Data Integrity” in clinical trials. Data integrity in generic terms can be defined as “maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.

Dr Bodo Lutz, Data Integrity Officer,Germany

SELECTBIO’s 2nd International CRO/Sponsor Summit on Data Integrity in Clinical Research was conducted on 2nd and 3rd March at Hotel Orchid, Mumbai. Proceedings was started by welcome address of Dr Sanjay Bajaj, Managing Director, SELECTBIO. Followed by Inaugural address delivered by the Guest of honour – Dr K Bangarurajan, Deputy Drugs Controller, CDSCO. Panel discussion was been held by renowned panellists. Discussion with delegates on the topic of ‘Data Integrity issues: Root cause and practical solutions’ on GCP guidelines, Intended manipulation of data, QA and QC looks in Data Review. First speech was delivered by Dr Diego Herrera, Head of Global Data Management from Almirall SA, Spain on Data Integrity Journey in Clinical Trials from Sponsor perspective. He explained the topics like sponsor responsibilities, data life cycles in clinical trials. In the topic of Sponsors perspective on Data integrity, patient safety, importance of audits safety, challenges which are faced currently and how data integrity can be strengthened. Dr Bodo Lutz, Data Integrity officer from Novartis Germany also explained the current situation of Pharmaceutical industry and

Asia LabEx 2017
Panelists K Bangarurajan, Ravindra Bhavsar, Ravishekhar Kasibhatta and Chitra Bargaje

CRO companies w.r.t data integrity concerns, root cause, challenges and how to identify and mitigate risks.  In other speeches delivered by speakers global pharma sales, expectations from CRO, regular perspective for clinical trials, expectation from well trained personnel and its compliance to GCP/GLP with well established QA procedures. In Quality Assurance programme in Clinical studies essential elements of QA programme was discussed of role, purpose of QA. And problems faced in Data Integrity like data alterations and manipulations.  Challenges of GCP compliances was comprised of Data integrity and human protection along with evaluation of ethics and regulatory guidelines and increasing protocol complexity. Process of medical documentation in India was also discussed. Other topics were bases on Regulatory inspection management, role of bioanalytical in data integrity and risk mitigation programme in CRO.

 

SELECTBIO’s 2nd International CRO/Sponsor summit on Data Integrity in Clinical Research was a successful conference with over 17 speakers from USA, India, Spain, Germany,  and Switzerland. Interaction between the delegates and speakers was influential and speakers ensured that Data Integrity is an key step in Clinical Research with  better future perspectives and opportunities. Sci Journo feels proud to be media partner for such knowledgeable events that provide way by which scientific excellence is achieved and we are the part of that progress.

Delegates, speakers and SELECTBIO’s team

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