Business Continuity Solutions and Challenges in Clinical Research

Business continuity solutions provide a sustainable route to strengthening resilience and agility across clinical research and the wider pharmaceutical industry.

In a research landscape where ongoing challenges including critical skills gaps, talent shortages and digitalisation hurdles continue to disrupt timelines, actionable business continuity solutions are in high demand.

Read on to discover:

• Top business continuity challenges in clinical research
• How to assess risk to your clinical programme
• Why upskilling strengthens business continuity

Top business continuity challenges in clinical research

1. Talent acquisition and retention

Global research organisations continue to face growing laboratory technician shortages, with the UK alone requiring an additional 700,000 technicians by 2030. 

For those organisations that do attract talent, retention poses an additional hurdle. National Technical Development Centre Director, Natalie Kennerly, suggests that graduates are not always ‘work-ready’ or equipped for the practical processes, and fast-paced problem-solving laboratory environments demand.

Meanwhile, insufficient job classifications and an absence of clear career progression are exacerbating difficulties in retaining laboratory technicians. Few organisations are stepping up to combat these issues - merely 39.6% of employers equip lab techs with continued education options. 

2. Skills shortages

As the wider pharmaceutical industry seeks to digitalise, drug discovery and development research is becoming increasingly high-tech, driving a need for digital skills in the laboratory, alongside existing skills shortages. 

While recent industry analyses led by the Association of the British Pharmaceutical Industry indicate some progress in repairing more general skills gaps across biological and chemical science, there are persisting areas of concern. 

Priority skill shortages include informatics, computational, mathematical, and statistical skills – all crucial competencies for a holistic digital strategy. 

3. Increased cybersecurity risks

Cybersecurity risks are emerging alongside increases in digitalisation and pose the greatest risk of supply chain disruption across pharma.

For laboratory leaders, mitigating the risk of cyberattack disruption will involve prioritising both risk and cost when building supply chain networks.

McKinsey’s post-covid sector analysis includes the following recommendations:

• Consider excess capacity in the global network to enable flexibility
• Increase the extent of dual sourcing
• Diversify partner portfolios
• Adopt near-shore or local strategies

4. Headcount restraints

Alongside the complexities of expanding and adapting the workforce to repair skill gaps and strengthen business continuity, headcount restraints often mean increasing workloads, and minimal staff on-site – a combination that can work against employee retention strategies.

Alternatively you can collaborate with a scientific services business, such as Synergy Scientific Solutions, where the costs of trained scientific and clinical technicians work at your site and fall under OPEX budgets, and not FTE expenditure, enabling laboratories to expand their personnel and maximise the potential of their laboratory’s space and equipment without the same budget concerns, or restrictions.

How to assess risk to your clinical programme

Agile and resilient business continuity plans start with holistic risk assessments that activate transparency across both research, and supply chains. 

These risk assessments provide a nuanced view of where vulnerabilities, and opportunities lie, enabling leaders to both protect, and strengthen resource allocation and management where most relevant. 

Step 1. Identify disruptors

Identify and list the key disruptors most likely to be faced by your organisation across your critical functions and operations.

These could include:

• Cyber-attacks – Is there a clear strategy in place to protect data?
• Supply chain issues – Are there single sourcing vulnerabilities?
• Research participant safety – Can you ensure uninterrupted care of research participants or clinical trial patients at investigator sites?
• Ability to work remotely – Are back-up personnel cross-trained to conduct critical tasks?
• Monitoring if workers are offsite – Are employees sufficiently trained to conduct offsite monitoring?
• Data integrity -  Can you assure that any unplanned reactions (e.g, medicinal transfer from clinical trial sites to patients) will be documented, scheduled and performed to standard?

Step 2.  Estimate the probability of occurrence, and the level of impact

Use risk assessment planning tools, such as a probability matrix, to reliably assess how likely disruptors are to occur, and how severe their impact would be on business continuity.

Key risks likely to affect clinical laboratories include:

• Geopolitical risks
• Human capital and employment risks
• Economic risks
• Legal risks
• Infrastructure risks

Step 3. Develop strategies for prevention

Using your findings, develop personalised strategies for prevention based on your company’s resources, and the potential impact level of occurrence on business continuity. 

For those incidents that may be unavoidable, develop a resource of key mitigating measures to minimise consequences and severity of occurrence.

These could include seeking additional expertise to supplement existing functions, and bolster resilience, or investing in building them internally.

Synergy Lab Services support clinical laboratories to expand their teams internally while avoiding employment risks and headcount limitations. This is achieved through our insourced teams receiving payment via OPEX budgets rather than FTE expenditure.

Why upskilling strengthens business continuity 

SRG’s 2022 Global Science Employment Report revealed that the skills gap is pertinent for STEM business across the world. 64% of UK STEM workers, 67% of European STEM workers, and 71% of US STEM workers are currently experiencing a skills deficit in their workplace. 

To be truly successful, business continuity plans should strengthen operating models, and their workforce in tandem, carving new avenues for professional development that align with strategic goals and secure continuity even across times of change.

Shifting priorities post-pandemic are driving an increase in hybrid work even in laboratory environments. SRG’s research shows that most STEM employees cite a good work life balance as the most important factor for them at work. However, without appropriate frameworks in place, hybrid models of work can be challenging to accommodate in research contexts. Upskilling and cross-training teams can offer laboratory leaders a reliable way to activate more hybrid opportunities, while preserving research continuity and agility.

Meanwhile, as digitalisation and automation become more commonplace in research, laboratory leaders should seek to accommodate improved professional development options for workers to both prepare for emerging skills gaps, and repair existing ones. Doing so will enable your research organisation to keep pace with competitors, and preserve continuity through new technological efficiencies, rather than being hindered by them. 

Synergy Scientific Solutions: providing business continuity solutions for clinical research

Synergy employ teams of trained scientific professionals who work alongside your staff on-site, providing flexible and agile resource support to repair skills gaps, and power business continuity. 

Our business model empowers research organisations to package routine high value scientific activities into their scope of work with pre-agreed deliverables, and costs. Our technical teams are equipped with continuous lean training and additional managerial training and development, that enables them to complete routine scientific activities with little error.

This frees permanent staff within your clinical business to redirect their attention to ROI generating activities including strategy, and complex scientific analysis, while improving their workload and likelihood for retention.