As the number and complexity of clinical trials continues to grow across the Asia-Pacific (APAC), so too does the strain on the systems that support them.

An estimated two-thirds of clinical trials involve the use of a registered pharmaceutical product. These include comparator, co-therapies, standard of care and rescue medications. Across APAC, sponsors of clinical trials are typically responsible for covering the costs of these products during the trial. 

Demand for clinical trial sites to supply registered pharmaceutical products is on the rise, adding complexity and increasing workload.

The challenges

Sponsors and CROs

Project management

Managing clinical trials and contractual agreements requires coordination across multiple sites, which can be time-consuming and lead to delays in trial initiation. Monthly billing and account reconciliation for multiple sites adds another layer of administrative burden, requiring meticulous oversight to ensure accuracy and compliance.

Barriers to feasibility in site selection

Identifying potential trial sites can be challenging as not all sites provide sourcing services or have experience with compounding. Sponsors and CROs often face difficulties in managing mixed-model sourcing strategies, which involve balancing centralised and decentralised approaches. Bulk ordering of clinical supplies often leads to high product wastage due to expiry and overage, thereby increasing costs.

Clinical trial sites

Ongoing reporting requirements

Sites are obligated to submit accountability reports on product use and stock levels. Without structured processes and systems, these reports can be time-consuming, inconsistent and take valuable team members away from clinical duties.

Communication and audit trail issues

Paper and email-based communication can cause difficulties for clinical trial sites. Formal notification and communication gaps between systems and departments can lead to stock overages and avoidable spend.

Hospital pharmacies

Escalating administrative demands

Hospital pharmacies are essential to clinical trial operations. They manage the ordering, storage, and dispensing of investigational and registered pharmaceutical products. Their responsibilities also include account reconciliations, contract negotiations, and financial reporting. In an already high-pressure environment, trial-related responsibilities add to the strain.

Inventory management complexities

The tracking and handling of clinical trial products can be complex. On-demand management of multiple investigator choice standard of care requires adaptable processes to prevent stock discrepancies and ensure protocol adherence.

Financial accountability for clinical trial products

Pharmacies bear accountability for accurate cost tracking of clinical trial product usage, particularly in multi-trial or high-volume settings. Clinical trial products dispensed through hospital pharmacy applications are often automatically linked to government reimbursement systems, which can cause reporting errors and necessitate lengthy reversals.

Simplifying processes with technologyTechnology plays an increasingly important role in streamlining clinical trial supply processes and reducing growing administrative burdens on sponsors, sites and hospital pharmacies.

The rise of secure digital solutions is helping reduce previously manual processes, while improving data security and unlocking both insights and efficiencies from ordering and delivery, through to invoicing and reconciliations.

For sponsors

Smart technology solutions can mean fewer contracts and more consistent reconciliation across sites. Inventory can be tracked in real-time, supporting more accurate forecasting and enabling just-in-time ordering to reduce waste.

For sites

Structured digital reporting tools and audit trails create clearer lines of communication with sponsors and pharmacies. Inventory levels are easier to manage, and formal notifications help prevent unnecessary overstocking.

Hospital pharmacies

Hospital pharmacies benefit from simplified account management and centralised systems that reduce the number of manual reconciliations. With the potential to integrate multiple processes into fewer systems, pharmacists can spend less time on paperwork and more time focusing on clinical care.

While clinical trials will always involve a level of complexity, the systems that support them don’t need to. By adopting purpose-built technology that facilitates collaboration and reduces administrative pressure, stakeholders across the trial supply chain can focus on what matters most: ensuring timely access to treatment for patients, and supporting the safe, efficient delivery of clinical research.