Time for a ReinventionWed, 09/07/2016 - 16:11
Q: After 11 years of managing pharmacological and biopharmaceutical research, what pushed you toward consulting?
A: It was time for a reinvention. Research, especially clinical, tends to follow the same patterns. The incorporation of new technologies and new approaches became necessary. QBD Consulting began proposing new approaches to clinical research while using new technologies and operating under a risk management approach. Collaborative efforts from players in the clinical research and IT arenas gave life to QBD Consulting. In return, we have given the industry a new approach to how CROs and pharmaceutical laboratories can conduct clinical studies. As most IT platforms used in clinical trials are provided by sponsors, we collaborate with CROs and Mexican pharmaceutical companies, since Big Pharma only uses their own solutions.
Q: What are the biggest needs of the clinical research industry in terms of quality and process optimization?
A: Although most sites and clinical research organizations have correct and orderly procedures, few have performed in-depth analyses of their processes. This is the main tool to see if procedures are in agreement with regulations and to identify risk factors. Analysis also identifies which processes could be automated. This allows times and costs of clinical studies to be brought down and helps us assure quality and compliance. One of the value propositions of QBD Consulting is the use of novel technology to satisfy the needs of our clients. We propose process analyses to pinpoint problems that are not seen by the organization, such as redundancies, lax controls and a lack of communication between areas. Many holes in the fabric of the trials become apparent and we can begin to search for solutions. IT can optimize many processes and QBD Consulting looks for solutions tailored to each client’s specific needs.
We implement electronic solutions for clinical trials. These can include eCRFs, eCH, and ePOR. All these solutions are provided by our strategic ally Digitalizatxt and offer the advantage that monitoring can be done in real time to detect any kind of anomaly immediately. Master file integration is done almost automatically. These solutions allow the sponsor to reduce the time of study, follow advances online, oversee all sites’ behavior and decrease the number of physical visits to the sites. This translates to a decrease in time and costs. Having control of the study assures clean and verified data and compliance.
Q: How open are clinical trial sites to acquiring technology solutions to manage their processes?
A: If all stakeholders participate in the first phase, people discover the advantages of new models and approaches. Concerning clinical trials, if you are able to clearly communicate the benefits of using electronic solutions, and convince them they do not imply double the work but a simplification of all red tape, they happily accept the reduced paperwork. Acceptance only happens after a period of reluctance. The results are what make them accept the change following a long and complex educational process.
Q: What certifications endorse the quality of QBD Consulting’s technology?
A: All our solutions have been developed following GAMP5, and they comply with Mexican regulations as well as CFR21. Some of the solutions developed by Digitalizatxt have been analyzed and approved by COFEPRIS. The company also participates at academic events to promote our solutions among industry experts.