CICATRIALS® ensures that all services provided to our clients are managed correctly with high quality standards, since all studies have a strict follow up through close clinical project management.

CICATRIALS® considers that the Clinical Project Manager must have an extensive experience as the leader of a team of professionals, and ensures that all study tasks will be done in accordance to clinical regulations, contracts, quality, and client requirements.

CICATRIALS® has a team of CRAs who perform all clinical activities related to qualification visits, initiation visits, monitoring visits, and closeout visits. All of our CRAs are focused on every detail of the clinical monitoring, ensuring complete adherence to the clinical trial plan and all national and international regulatory requirements.

In addition, all CRAs are involved in efficiency and quality management of clinical studies.

Our Medical Monitors assist our clients with medical data review and analysis of the clinical study reports. They can provide training for the study team and identify potential study risks, ensuring appropriate vigilance of patient safety.

The correct establishment, collection, management, interpretation and preparation of clinical trial data for submission can mean the difference between a successful trial and an expensive failure.

CICATRIALS® team extracts, analyzes and interprets your data, then prepares it for presentation to regulatory agencies. At the end of the day, our job is to help ensure that your entire project team is able to conduct compliant, cost-effective trials.

We focus on the intricate details of your study so you can focus on your trial and on providing new therapies to patients around the world.

CICATRIALS® has extensive experience in regulatory processes in México and LATAM, ranging from submissions to ethics committees and regulatory authorities, to importing medical devices, medicines, laboratory kits, and medical supplements, as well as exporting them back to their place of origin. Our regulatory team works hand in hand with our clients, providing effective support during these processes.

CICATRIALS® is certified in ISO 9001:2015, which ensures that all our studies are organized and conducted under strict quality controls at each of its stages.

Our approach includes a full suite of SOPs, full validation of computer systems and quality assurance oversight of all internal processes and documents.

In addition, CICATRIALS® complies with the clinical investigation requirements for medical devices detailed in ISO 14155. This is essential to streamline the review and approval of the MD by regulators and Global Market.