Incorporated in 1993 as a subsidiary of Biocon Limited, Syngene is a leading custom research and manufacturing organization, which supports R&D programs from lead generation to clinical supplies. Syngene, one of India’s and one of Asia’s largest drug discovery and development contract research organizations (CRO), have a clinical development team that provide full-service solutions for clinical development of drugs, nutraceuticals and medical devices. Their clinical trial services encompass phase I-IV clinical trials in patient populations at hospital sites across India.
They also provide bio-analytical services to support preclinical and clinical development programs of small molecules and large molecules. Their bio-analytical lab is GLP-compliant, and specializes in immunogenicity and pharmacokinetic analysis of biologics such as monoclonal antibodies, recombinant proteins, enzymes, biomarkers, cytokines and growth hormones.
Syngene has used ArisGlobal’s electronic data capture (EDC) solution, agCapture, in a number of studies, and has also used ArisGlobal’s randomization and trial supply management (RTSM) product, agSupply, in a previous study.
LIFE BEFORE CHOOSING A SOLUTION
“Previously, in our paper-based solution, once the study was completed, there was a huge lag in getting the pages and query resolutions to the database log after the last completed activity.”
Before Syngene adopted EDC, the company was using an elementary paper-based solution. Although this allowed it to do double-data entry, it found that the solution was becoming increasingly outdated. The company wanted a system that could do more in less time at a responsible cost. It was widely known from customer experience that there are more efficient tools for collecting data electronically, and they wanted to ensure that they were benefiting from it.
There were various other factors that influenced Syngene’s decision. For example, the improvement of its IT network in India gave the company the confidence to implement EDC. “The infrastructure change helped Syngene to know that EDC was now a tactically viable solution for improving the efficiency of clinical trials”, explained Dr. Anand Eswaraiah, Head of Biometrics, Medical and Regulatory Affairs at Syngene. He noted how poor the telecom infrastructure used to be, and how much it improved during the digital revolution in India.
To achieve its objectives, Syngene needed a system that would do data capture in a more efficient manner than paper-based trials. Although data integrity is an important aspect to consider, it was more pressing to the company that it had a solution that would enable it to fully realize the benefits of quicker turnaround times in efficiencies. The focus was now on complying with regulatory standards. Syngene had used a number of EDC systems in the past, and was now ready to adopt a solution that was up to the task.
By not adopting a new solution to meet its new challenges, the company risked losing out on potential opportunities. “Without the right solution, our clients would not have been able to put the product on the market as they would not be able to complete trials quickly enough, while ensuring they were meeting the correct regulations,” clarified Dr. Eswaraiah.
REASONS FOR CHOOSING ARISGLOBAL
“ArisGlobal’s collaborative approach to future release development certainly influenced our decision.”
One of the main reasons the company chose the ArisGlobal solution was its flexibility to integrate with its clients’ systems. From the beginning, the company wanted to go for a small/medium-sized EDC provider with whom they could work with to customize the solution to their requirements. Syngene wanted to offer EDC as software as a service (Saas). The company wanted to adapt this solution to their clients’ system requirements, which is why the company approached ArisGlobal to customize it.
Price was also a consideration in this decision. Syngene thought the ArisGlobal pricing model was very reasonable and matched its budget. In a competitive environment where clinical development costs are rising, it was important to find a reasonably priced solution that would fully accommodate Syngene’s requirements, being sensitive to the fact that pricing pressures are something that many firms are facing.
“Flexibility and pricing were both very important factors. This was one of the key reasons why the bigger companies were not considered. Bigger software firms would never customize to our requirements,” Dr. Eswaraiah explained.
Dr. Eswaraiah eventually saw a demonstration of agCapture, and was impressed with its ease of use, excellent features, and good navigation. Syngene had some idea of what it expected; it required intuitive navigation from the end-user perspective (especially when dealing with doctors, where time is important); needed to be as easy to use as possible; and have good summary and reporting functionality. The company also required a randomization and supply chain tool, which it used in its first trial. ArisGlobal’s unified EDC solution met these expectations.
Having the right technology is essential. It is also important to select the right people to do business with. Syngene was looking for a partner that would support their requirements by providing a personalized solution that would deliver. “ArisGlobal’s collaborative approach to future release development certainly influenced our decision. It also helped that the data management team were extremely friendly and very supportive. This, coupled with ArisGlobal’s breadth of life sciences solutions, gave us confidence in their approach to creating and supporting any solution” Dr. Eswaraiah explained.
“We saw an immediate 25% improvement in efficiencies.”
Syngene has benefited from many efficiencies gained in EDC over paper-trials. “End users benefitted from a very user-friendly system and could really see what was happening on a real-time basis. Paper-based systems were opaque in terms of retrieving the pages on an on-going basis and it was hard to show transparency to the study team and other stakeholders. We saw an immediate 25% improvement in efficiencies,” Dr. Eswaraiah said, adding that the solution made it easier to check how many visits had been completed; what the visit schedule looked like; what kind of data it was getting; raising queries and answering them in real-time; as well as being able to upload certain documents in the EDC, which is not typical in other EDC systems.
The company also discovered that it could go through the database log more quickly, allowing to clean the data earlier. “Previously, in our paper-based solution, once the study is completed, there is a huge lag in getting the pages and query resolutions to the database log after the last completed activity. EDC could complete the database lock a lot quicker, leading to a 25% improvement in study completion time,” said Dr. Eswaraiah.
Syngene found that its initial requirements were met when it successfully moved from paper to EDC. EDC was its choice for the flexibility and transparency to allow the team to look at the data and produce the required reports. It also provided a complete snapshot of every aspect of the study. Dr. Eswaraiah explained, “From an end-user perspective, the system was easy to use and delivered the business outcomes we expected. One of the strongest features was the system’s ability to link other pages in pre-populating data. For example, it could link an adverse event (AE) to any other page seamlessly. Supplies and the alerts which were required when the stocks were getting depleted were getting delivered on time.
“Some of the features found on agCapture are not available in more advanced solutions, and with the inclusion of RTSM, which is also good, the system works well.”