Express Pharma

Revolutionising outcomes: Agile CROs lead the way

Vivek Chopra, Partner, Vector Consulting Group, and Alka, Senior Consultant, Vector Consulting Group detail the evolving role of Indian CROs from research facilitators to valued partners and recommend strategies for CROs to enhance productivity, reduce errors, and improve customer satisfaction

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Clinical trials attest to the safety and efficacy of pharmaceuticals. But, they’re not cheap to conduct. By 2020, out of the mammoth $200 billion pumped into pharma research, a whopping $48.4 billion went into clinical trials. Given the current trajectory, the figures could balloon to $68.9 billion by 2025 and approach $84.44 billion by 2030.

CROs: The torchbearers

To strike a balance between quality and cost, global pharmaceutical giants have, since 2005, leaned towards Indian clinical research organisations (CROs), especially for generics. This was catalysed by India’s alignment with the TRIPS Agreement. India’s draw mainly lies in its lower overall costs, pool of expert scientists and large volunteer base. Consequently, India now anchors about 20 per cent of global trials.

However, the economic advantage once provided by India is waning due to escalating costs. Undeterred, Indian CROs are evolving, pivoting from being mere research facilitators to valued partners who promise global standards and swift study timelines.

Setting CROs apart: Excellence and speed

It is well known that fast-tracked generics pharma products garner market advantage. Afterall, every subsequent generic launch chip away at the price. Therefore, while cost matters, pharma firms also measure CROs by their ability to deliver quality research results quickly.

CROs’ hurdles

CROs envision impeccable services for their clientele. This encompasses quick feedback loops, expedited study design, swift regulatory nods, better volunteer access, and efficient study execution. But this ambition often meets roadblocks:

  1. Initial proposal bottlenecks: Sometimes drafting a proposal to send to a client becomes a drawn-out affair, sometimes pushing clients to explore other CRO options.

  1. Protocol designing hiccups: Once a client is onboarded, protocol design if rushed through and done without proper due diligence, can lead to errors. Further resulting in extended approval cycles to start study or poorly designed study to start with.

  1. CRD’s juggling act: Clinical Research Departments (CRD) often find themselves overloaded, causing essential activities to be overshadowed and subsequent errors/rework when trying to rush.

  1. Training gaps: With doctor’s limited available capacity and extensive training needs for support teams before the trials can begin, the coordination for training becomes difficult. As a result, the training regime often suffers, leading to errors during the trials.

  1. QA stumbling blocks: In a highly regulated environment, all issues need to be reported and resolved. It becomes difficult for Quality assurance getting hamstrung by constant backlogs. This slow response mechanism further compounds issues

  1. Report merging delays: After trials, coordinating for reports across departments becomes a herculean task, delaying the final report dispatch to patrons.

Diagnosis and remedies

What is evident is that since CRD (especially PIs) contribution is needed for all the tasks from proposal to report, managing their time efficiently and productively is the key to breaking free from this vicious cycle. Some decisive actions are required for this:

  1. Redefine CRD tasks: Dedicated teams can spend quality time either taking care of feasibility responses or in protocol preparation as required. This will ensure these tasks are done on time without interrupting current studies.

  1. Implement work prioritisation: An agreement on priority and limiting number of tasks handled simultaneously can help CRD complete pressing reports fast without stretching themselves thin.

  1. Streamline processes: Processes have to be set up to ensure that time available for nurses, phlebotomists, and PIs in between their regular rounds of current studies is optimally used to close open observations from previously concluded studies that need their inputs

  1. Faster detection and resolution of error: Processes should enable to raise and resolve queries on current studies on ongoing basis, so as to reduce open issues post completion of study.

  1. Adopt train the trainer approach: Decentralised protocol training in small groups can ensure better retention and application and reduces the challenge for sync

Some new work practices also have to be adopted:

  1. Align inter-departmental workflows: A shared priority framework can enhance inter-departmental cohesion and timely report completion.

  1. Kick-off only post readiness: Ensure all prerequisites are ticked off before diving into tasks to minimise disruptions and waiting for information.

  1. Shift from deadlines to task frequency: Daily monitoring can pre-empt issues, encouraging proactive solutions.

  1. Boost transparency: The daily monitoring of individual tasks in a study can be enabled by a project management software system providing the expected time of completion (ETC) of all reports. This goes a long way in providing visibility and timely actions.

Conclusion

Adopting these steps can amplify efficiency, potentially cutting down observations/deviations by 40-50 per cent and hastening report generation by 25-35 per cent post-trial. Such prowess not only facilitates CROs to handle more studies but also skyrockets client satisfaction levels. With cleaner processes, regulatory queries post-submission can also dwindle. CROs able to achieve this proficiency position themselves as indispensable allies to their pharma clients.

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