Changing paradigm in laboratory services
Intervein is the example of the changing trend in laboratory services in India
Intervein, the central laboratory, which commenced operations in 2006 has a focused business model of catering to clinical trial samples only. It is one of the few central laboratories in the country providing such services to clinical research. “Although lab tests provide 90 percent of all the data that comprise a new drug application, selection of laboratory service was never given its due attention,” says Dr Shivprakash, Founder Chairman of Intervien.
In the past, study protocols required safety panels involving mainly routine analysis such as biochemistry and hematology. Lab values were generally needed to evaluate a drug’s safety and not its efficacy. Statisticians did not use lab results as major end points. As a consequence, sponsors doing clinical research used local labs available in the vicinity of the investigators. And each of these labs used different methodologies, reference ranges, units, reagents and kits. Even simple prerequisites like staff training differed in quality. Such discrepancies showed in the lab results, which complicated the entire data compilation. But now the drug developers have become aware of the importance of laboratory testing.
“Intervein has the experience of managing clinical trials across various sites. It is very important for a central lab to understand the intricacies of a protocol, regulatory requirement etc. Our dedicated team is GCP/GLP trained. They have a sound knowledge of FDA/ other countries’ regulatory requirements,” says Devina Bhardwaj, CEO, Intervein. The lab provides 3 key services— data mangement, clinical development and strategic planning functions, which have become the need of the hour for the drug developers.
Pharma/biotech companies today are on look out for laboratory capabilities like combinable data, traceability and audit trails. Intervein has a web based reporting system, which is capable of providing data in real time. Intervein uses consistent reference ranges, units, reagents, instruments etc. throughout the study. This makes it easier for the sponsor to merge the data in their database while submission of the data for the entire study. “To overcome the errors and improve traceability, visit specific collection kits which are bar coded are sent to the investigator site.
This helps the samples from the various sites to reach the lab in a homogenous way. Also, since the collection tubes are pre-bar coded, the specimens are easily traceable. Missing tests or missing values can be identified easily and rapidly at the time of data analysis at Intervein,” said Bhardwaj.