Why You Want a Lean Coached Team Managing Your Trial

With the end objective to accurately deliver what the customer wants when they want and with the highest possible quality and flexibility, the result of working with a Lean Coached Team is greater efficiency, effectiveness, and agility for your clinical program.

Three Ways Application of the Lean Methodology & Tools Benefit Your Clinical Program

Clinical trial sponsors with concerns about timeliness, and quality of results will clearly benefit from a clinical operations team that is Lean Coached 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 in regard to both sites and patients.

A Lean Coached CRO’s clinical operations team is able to deliver the benefits outlined above because the Lean quality management methodology implies a structure that supports designing all processes to deliver the clinical trial sponsor impeccable trial monitoring results.

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

For the Lean Coached CRO’s team, through the principle of continuous improvement, flexibility and agility is consistently engendered at the team level. Making the Lean Coached clinical operations team poised to adapt to changes by making the 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 streamlining all processes that do add value and minimizing quality standard exceptions.

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 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, is 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.

Whatever the unique requirements of your oncology clinical trial, with its proven track record bundled with 25 years of lessons learned Scimega offers an effective Lean Coached team of experts who work together seamlessly for your study success.

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

   Contributed by: Maëva Roques, Lean Ambassador