Frequently Asked Questions

Brainmart is a Site CTMS (Clinical Trial Management System) that digitalizes, standardizes and gives traceability to the research center's entire operation. It integrates in a single environment the clinical processes (EHR/eSource), operational (coordination, agenda, visits), regulatory (eISF, versions and expirations), care-related (pharmacy, laboratory) and administrative (settlements, payments, economic control of the study). It eliminates Excel, paper and parallel records, reducing errors and increasing the site's capacity to work with precision, efficiency and regulatory compliance (FDA 21 CFR Part 11, GCP, ALCOA++). Brainmart solves the site's main problem: the lack of order and traceability in an increasingly complex operation. In short: it lets you operate with greater efficiency, less risk and better economic control of the study.

Brainmart lets the site operate with levels of order, precision and traceability that are impossible to sustain with manual tools. By centralizing EHR, pharmacy, laboratory, eISF, agenda and administration in a single system, the team reduces repetitive tasks, minimizes errors and gains real operational time. The center achieves more predictable processes, verifiable information and a workflow that improves both daily efficiency and the relationship with monitors and CROs. In addition, digitalization strengthens regulatory compliance and reduces exposure to audit findings, increasing the site's competitiveness with sponsors. In summary: it delivers real order, daily efficiency and a more solid, reliable clinical operation.

Yes. One of Brainmart's most significant advantages is the ability to increase study volume without expanding structure. This is achieved because the system drastically reduces the operational load associated with manual records, information reconstruction, document control, administration and task follow-up. Per-protocol standardization, together with contemporaneous recording and module integration, avoids duplication and rework. In this way coordinators, PI, pharmacy and administration can absorb more protocols by working on clear, digitalized and replicable flows. The result is a more scalable and economically sustainable operation.

Yes. Brainmart eliminates the main sources of operational error: Excel records, outdated information, duplicated documentation and lack of traceability. The protocolarized EHR ensures clinical consistency; pharmacy and laboratory record movements with an audit trail; and the eISF consolidates single versions. Every change is documented and every activity is protocolarized, which avoids rework and reduces the corrections requested by monitors. In addition, automatic alerts prevent expirations and omissions that usually generate deviations. This lets the team spend less time "fixing" and more time executing the study correctly, speeding up the whole operation.

Yes, because it digitalizes and structures the study's evidence according to international standards. Monitors and auditors access consolidated, validated and traceable information, without depending on emails, physical folders or scattered versions. Brainmart records who did what and when, and centralizes EHR, pharmacy logs, kits, regulatory documentation and monitor comments. This allows deviations to be detected before the audit and ensures the integrity of the source data. The result is a more agile audit process, with fewer observations and greater sponsor confidence in how the site operates. In short: it simplifies audits and reduces findings by offering clear, accessible and fully traced evidence.

Yes. Brainmart replaces Excel, notebooks, folders and parallel records with a single system that brings together all study processes under eSource regulatory criteria. This not only eliminates information duplication, but transforms previously informal records into clinical-operational evidence that is valid before audits. Coordination does not need to keep separate sheets, pharmacy does not manage manual inventories, and the eISF integrates documents in controlled versions. By fully digitalizing the flow, the site leaves behind the risk of paper and obtains a modern, orderly and fully audited operation.

Brainmart does not replace the sponsor's systems (EDC, IWRS, eCRF, corporate CTMS). It integrates operationally as the site's internal management tool, ensuring that everything that happens at the center is orderly, traced and ready to be reported in external platforms. This means the site works on standardized processes, avoiding inconsistencies between what is documented internally and what is uploaded to the sponsor's systems. The CRO also benefits, as it finds complete, contemporaneous and auditable records, which reduces monitoring times and observations.

Yes, always under the site's control. Access is enabled only if the center decides so and only with read permissions. The Oversight module allows sponsors and CROs to view operational metrics, validated documentation and study progress without intervening in the operation or modifying records. Access can be configured by protocol, role and time validity. This controlled transparency improves communication, speeds up reviews and reinforces confidence in the site's performance without compromising information security.

Yes, but not through commercial intermediation, rather through partners and at the same time with better operational performance. A site that documents with precision, shows complete traceability, responds quickly to monitors and presents documentation in compliance is a site preferred by sponsors and CROs. Brainmart makes it possible to demonstrate objective quality indicators: lower error rate, better-documented visits, traceable logs, less rework and consistent processes. This increases the sponsor's confidence that the center can execute complex studies and sustain greater volume without compromising regulatory standards.

There is no direct cost for the site. Brainmart uses the DDA (Digital Data Agreement) model, which allows the technology license to be included in the protocol budget and funded by the sponsor, in the same way as supplies, personnel or study logistics. This removes economic barriers, facilitates technology adoption and aligns incentives: the site only pays if the study advances and generates revenue.

Brainmart is validated to operate as eSource and complies with the industry's main regulatory standards: FDA 21 CFR Part 11 (record control and electronic signature), GCP (Good Clinical Practice), ALCOA++ (attributable, legible, contemporaneous, original, accurate, complete, consistent and available) and data protection regulations (GDPR, Habeas Data). This guarantees that every record within the system has legal and regulatory validity and can be presented to sponsors or regulators without needing to duplicate information on paper.

The monitor accesses the system with a restricted user and can review EHR, documentation, logs and study activities without needing to request files or coordinate on-site visits. They can leave comments directly linked to the patient, activity or document, and the site manages those observations from a single interface. This reduces the total time of each monitoring, speeds up the closing of pending items and improves data quality by allowing early corrections. The site gains operational fluidity and less interruption to its daily work.

Brainmart uses encrypted infrastructure, role-based access controls, complete action auditing and per-protocol segregation to guarantee data security. Every modification is recorded; there are no overwrites or informal records. The system complies with international data protection regulations, ensuring the confidentiality of patient information and continuous system availability. In addition, its cloud architecture avoids risks associated with local storage and offers redundancy and permanent backup.

Brainmart integrates all the site's processes into modules that work together: Site CTMS for coordination and visits; protocolarized EHR for source data; pharmacy for inventory, dispensing and logs; laboratory for samples and kits; eISF for regulatory documentation; agenda for daily activities; administration for settlements and economic control; and Oversight for external visibility when the site authorizes it. This integration avoids duplication and enables a fluid, standardized and fully traceable operation.

Brainmart offers continuous support from the initial implementation to daily operation. Each site role (coordination, PI, pharmacy, administration, laboratory and monitors) receives specific training oriented to their real workflow. In addition, the support team provides technical and regulatory assistance, helps with audits and resolves operational questions. Product updates are permanent and do not require site intervention. The goal is for the center to adopt a solid, sustainable digital operation aligned with best practices.

Excel lets you organize information, but it does not meet regulatory requirements, does not ensure traceability and does not integrate critical processes such as EHR, pharmacy, laboratory, eISF and administration. With Excel, the site depends on manual records that are vulnerable to errors, data loss and audit findings. Brainmart turns the entire operation into audited eSource, with standardized processes, version control, audit trail and real centralization. This makes it possible to work with greater precision, reduce risks, avoid rework and scale studies without overloading the team.

Brainmart generates operational and economic benefits: ✔ Greater operational capacity: you can manage more protocols with the same structure. ✔ Lower cost per study: by reducing hours of coordination, documentation and audits. ✔ Greater profitability: fewer manual tasks → fewer unproductive hours; fewer errors → less rework; fewer deviations → cleaner audits. ✔ Greater operational speed: which impacts better metrics with sponsors/CROs. ✔ Lower financial risk: it avoids losses from unbilled visits, payment errors or incomplete records. In short: Brainmart makes your center work better and more profitably without needing to expand staff.

Brainmart has a network of specialized partners that complement the site's digitalization with key services to improve the center's performance. These allies provide solutions in patient recruitment, sponsor outreach, administrative and accounting management (ERP), business intelligence, tools for decentralized studies (DCT) and services associated with clinical operation. Integration with these partners allows the site to expand its capabilities beyond the CTMS, incorporating structured processes that strengthen the center's efficiency without increasing its internal load. Each partner brings specific expertise that articulates with Brainmart's flows to offer a more solid, scalable and competitive operational ecosystem with sponsors and CROs. In short: it expands the site's reach with complementary solutions that strengthen recruitment, administration, DCT and analysis, boosting the entire operation beyond the CTMS.