Skip to content

What Can Your Trial Gain When Your CRO is Lean?

The need to transform traditional clinical trial processes to a leaner and more cost-effective model is increasingly important. Sponsors of clinical trials with concerns about timeliness, and quality of results benefit from a Lean clinical operations team with the following:

  • A clear focus on activities and processes designed to deliver on your clinical trial what you want when you want it, in regard to feasibility, enrollment, first patient in, eTMF, and any other attributes that are absolutely crucial to your trial;
  • The elimination of process variation and inconsistency in clinical trial activities;
  • Targeted improvements that provide the greatest efficiency, effectiveness, and agility for the achievement of optimum engagement for your clinical trial regarding both sites and patients.

Consistent, effective process improvement reduces delays and improves data accuracy in clinical trials where turnaround time and data accuracy are critical. The estimated cost of a one-day delay in a drug being brought to market can be significant. Just as paperwork-based errors in the clinical trial process – whether they occur at the sponsor level, the contract research organization (CRO) level or the institutional review board (IRB) level – can result in serious effects that can negatively impact study efficacy and time-to-market.

Some forward-thinking companies have begun to see success as they explore and embrace new ways of working. This ability to react to changes as they emerge in today’s rapidly evolving landscape for clinical research is the key driver for change in 2024 and beyond.

What Lean Means at the Clin Ops Team Level for Your Trial Geographic Expansion

One way that Scimega has invested in our team and one strategy that sets us apart from other CROs is that our company has adopted a Lean six sigma methodology. Our entire team is coached in lean processes, we have an in-house Black Belt to lead our Lean projects, and several of our operations team are Lean certified.

Ongoing updates to our processes and systems based on Lean methodology cuts out any of the extra noise, and as a result we are even more cost efficient as we have been able to focus our efforts in the areas that matter most, all while following GCP and all other required regulations of course.

For the Lean Coached CRO’s team, through the principle of continuous improvement, flexibility and agility is consistently engendered at the team level. This means the Lean Coached clinical operations team is ever more agile and poised to adapt to change by making necessary adjustments to achieve optimal engagement.

This dedication to customer satisfaction, based in a sound methodology, underlying principles and structure, sets the Lean Coached CRO’s team apart from other CROs that choose to not embrace continuous improvement as a core means to effectively meet their sponsor’s clinical trial milestones.

The quality management methodology adopted by the Lean Coached CRO’s team is a structured approach. In this case, what quality means to the sponsors is mapped out, along with specifically how this level of quality service is to be consistently delivered to them. This requires that the Lean CRO’s clinical operations trial management services offering is consistently delivered to the sponsor while at the same time continuing to streamline any processes that add value and minimizing quality standard exceptions.

The silver bullet for ensuring that a Lean methodology truly can attain: (1) a clear focus on activities and processes designed to deliver on your clinical trial regarding feasibility, enrollment, first patient in, eTMF, and any other attributes that are crucial to your trial; (2) The elimination of process variation and inconsistency in clinical trial activities; along with (3) Targeted improvements that provide the greatest efficiency, effectiveness, and agility for the achievement of optimum engagement for your clinical trial regarding both sites and patients is pairing Lean with a solid team.

Some tips on how you might achieve this can be applied when hiring your CRO and include: Interviewing CRAs/PMs, and other vendor team members when you outsource; Collect questions and feedback on the protocol/study set-up versus site policies/SOC, and ask for a list of possible risks along with suggestions to avoid/mitigate them ahead of time; Add ‘staff assignation approval’ in your agreements; and Apply vendor audit rigour regarding systems and sub-contracting inquiries early in the engagement process.

Scimega a Lean Niche Canadian CRO

The smaller, niche CRO that is well managed, with low turnover, and a clinical operations team populated with Lean Coached experts in oncology provides a living archive for your program development over the long term. At Scimega the same project team follows a Sponsor’s program from Phase I to II, and subsequently heads any scale-up to Phase III that follows. Thereby providing not only the necessary therapeutic alignment of personnel, but also the accessible knowledge of what is and has gone on with a study program from its outset.

Throughout its 25-year history Scimega has been dedicated to continuous improvement at the core of the value it provides. As company President & CEO, Julie Martin, puts it: “adopting a Lean methodology to lead our continuous improvement program, launched by our Black Belt Lean Ambassador, and coached by the proficient and renowned group, The Lean Six Sigma Company, was a natural next step for Scimega in 2023.

Julie elaborates on what adopting Lean really means at Scimega:

  • Greater efficiency to our clients;
  • Enhanced team focus on value added specific to each client;
  • Our constant examination of internal processes to customize the best process path for each client;
  • Deliverables: faster and always at high quality;
  • Less use of ‘quick/quickly’, and more use of ‘efficiency/efficient’ process optimization;
  • Faster lead times;
  • Better faster services than the competition;
  • A constant pursuit of ways to be better;
  • Seeking a sustainable way to conduct research for our clients.

She goes on to say that in part this is done by adopting a focus on value-added for each of our clients. This intrinsically implies that together our team contributes to shared objectives regardless of function or department, with the overall aim of Lean at Scimega leading to even higher sponsor satisfaction and improved organizational results.

In every instance Scimega works with your team to devise innovative solutions to address your unique challenges, bringing together the right combination of specialized expertise for your cutting-edge oncology trial.

Scimega’s team of Lean Coached oncology experts go above-and-beyond to provide: Local, full-time, permanent hires for exceptional staff quality; An extensive network of Canadian Investigator Sites that frequently emerge among top enrollers, and are activated 50% faster than average for global studies; Optimal site engagement to maximize quality, timely data entry and query resolution; Robust and Lean Scimega methodology and processes are supported by current technology to keep every trial this CRO monitors on the Lean trajectory.

If you’re interested in learning more about the Canadian opportunity, explore an expansion with us!

canadian_investigators_icon Contributed byJulie Martin, President & CEO

Back To Top
Search