Maintaining a Quality System in a Small Scale Company: Q-Trials CRO Tips

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Quality is a parameter that cannot be overestimated in the field of clinical trials.  Clients, Medical professionals and ultimately the patients, depend on our high quality work hence this is not to be taken lightly.

Many small companies strive to achieve and maintain a high level quality system while balancing the constraints of running a smaller business at the same time. We, at Q-trials, are firm believers that this is possible to accomplish, although requires some investment and effort.

Here are some of our tips on how to achieve this:


People

  • Process owner:  for each SOP identify the most experienced process owner, ask them to write down their steps (or interview them), in chronological order, as if they are guiding someone who is inexperienced in this field of work.

  • External consultant:  when required, and every once in a while on a regular basis, contract an external expert consultant.  The right consultant would be able to look at your quality processes with fresh eyes and bring a perspective to the table that you might otherwise overlook. It’s an investment that will pay back and will ultimately improve the functioning of the company.

  • Processes administrator:  nominate someone from the staff to oversee the quality processes. At Q-trials, we have a part time Processes Administrator who is responsible to ensure that the company is compliant with its quality procedures.

Principles

  • Realize the need:  every company working in the arena of clinical trials is required to have and maintain a quality system of its own. Start constructing your quality system on a limited scale using your best tools, knowledge and experience available.

  • Keep it simple:  limit your formal quality system (SOPs) to GCP related topics and form policies for internal matters that you would like to follow.

  • Market:  take your written  procedures seriously, encourage your staff to review before important tasks are done. This approach contributes to the increased sense of responsibility and the pride for the work done well.  Standard operating procedures are not just something to read once and check off the list, but the go-to manuals for the day to day activities.


Logistics & Technicality of Quality Documents

  • Format of quality documents: establish or adopt a format and use it consistently throughout your writing process.

  • Language:  you may use local language, although English is handy for international parties review and audits. Use basic terms and brief sentences.

  • Filing:  file your SOPs in an accessible location, enable review only mode, discard of old or non-relevant SOPs in an acceptable fashion.


Actions

  • Review:  upper management should independently review and comment on the written procedures. Perform several rounds if needed, before finalizing and signature.

  • Training:  conduct centralized or self-training within the company. While it’s important to hire people with certain skills and qualifications, develop a robust internal training program. This will ensure that all employees are trained according to the same high standards. Part of the onboarding training for new employees at Q-trials is the thorough review and acknowledgement of the set of relevant SOPs. In addition, facilitate pairing up with an experienced team member, who ensures the training process is completed correctly and gives immediate feedback to the starting employee. 

  • Audit yourself:  initiate periodic self-audits of your quality system, or choose a sub-set of SOPs in a certain area for objective inspection. Complacency is the enemy of quality. It’s important to conduct periodic checks of the systems that usually result in improvement of actionable items that we work on continuously.

 
We believe that constant self-inspection and checking ourselves is key for further improvement and opportunities for learning how to do things even better. 


Dr. Ornit Yanai-Kohelet
Q-Trials CEO