CRO Services

Using a Patient Centered Approach that puts patients in the driver’s seat. Health professionals have found that when patients play an active role in their own care, they’re empowered, and results improve. Patient-centered care reduces unnecessary procedures, honors patient preferences, and improves patient health.

BRCR is dedicated to helping ensure clinical trials are more accessible and inclusive. Factoring insights and established goals into site selection, site training, and the recruitment strategy.

Patient access continues to be one of the biggest industry challenges impacting on time and cost in clinical trials.

Our Process

I. Discovery & Clinical Management

In this first stage, we will work together with you to determine the best place to carry out the clinical trial according to the requirements of the study and the protocols to be followed. We will be with you throughout the regulatory process of the chosen country, to ensure the legality of the activities to be performed. Our team will oversee site studies and feasibility to determine the best sites to perform the study. Our logistics team will support with transfer of drugs or devices in a safe and agile way. The goal is to reduce the times and costs in the development of the study.

II. Patient Recruitment & Retention

Patient recruitment remains one of the greatest challenges in the development of clinical trials. Our specialists will train site investigators for study conduct, managing a patient-centered approach for much higher retention. We will support the sites in the recruitment process, providing them with tools and resources to reach the largest possible number of people interested in participating in the study, as well as management tools to keep proper control and ensure the validity of the study data.

III. Monitoring & Study CloseUp

As the study progresses, our project specialists will be constantly monitoring and sharing data with you. Our quality policy foresees that the whole process is extensively monitored, with real-time data for better and faster decision-making, shortening time, and generating fewer costs in the development of the study. Once the study is concluded, our specialists will share all the data obtained with you and will carry out the necessary procedures to close the study

Project Management, our biggest strength and competency, it’s backed by a streamlined set of processes, in conformity with the diverse regulatory requirements present in the global market. Performance and costs are closely monitored and measured to guarantee the correct adherence to agreed budgets, always aiming to perform in the most timely manner and cost effective way.ur core competency, project management is underpinned by comprehensive and consistent processes, which conform to global regulatory requirements.

Services you can access include:

• Project management of clinical development programs.
• Agile clinical monitoring – On-site, Remote and Centralized Monitoring.
• Optimized balanced resourcing – applying advanced models and predictive analytics.
• Smart study start-up – using streamlined processes and leading-edge technology.
• Site and patient solutions – recruiting, engaging and retaining patients.
• Fast delivery of high quality and meaningful data means that you can make well-informed decisions earlier in the trial. This also ensures patient protection and reliable trial results.

Clinical Supplies Management: BRCR CRO Logistics team strategically manages all your clinical trial logistical needs across the globe, integrating seamlessly into your study’s operations. Our locally based staff and depots provide you with the specialized knowledge needed to run an efficient clinical trial.

Our regulatory teams will work with you to develop a regulatory strategy early in the development to identify key challenges that may arise, and to interact collaboratively with the IRB’s, FDA, EMA, European and international regulatory authorities. This will ensure that your plan is aligned with the product profile and commercialization requirements.

A regulatory partner that has you covered:

• Regulatory project management and submissions
• Regulatory technology and information management
• Labelling, including content development, project management, document review and compliance
• Medical writing, quality control and editing services
• Regulatory CMC to ensure practices are compliant with global requirements
• Clinical trial transparency including complete trial disclosure lifecycle management

The first step is to gain an understanding of the targeted patient profile with respect to epidemiology, standard of care, treatment pathways and overall healthcare utilization. We then conduct a rigorous analysis of the current clinical trial environment, including competitive landscape, historical performance precedence, country ranking, advanced modelling and recruitment projections.

Key attributes of our feasibility and clinical informatics offering include:

• A global team of world-class feasibility experts and data scientists to process, interpret, and analyze data to support a winning strategy
• Immediate ability to query electronic health records on millions of patients to support study design, site, and patient recruitment
• Proprietary combination of site, trial, and drug intelligence databases to support operational planning of studies and programs
• Study design and protocol evaluation
• An integrated site network with direct access to Investigators to review study operations and resolve standard-of-care questions
• Access to the patient population to query study procedures and patient-centric approaches
• Time and motion programs to evaluate patient and site burden
• Quality control site performance data analysis
• Quantifying based on patient identification and validating sites’ access to patients

We have a robust quality policy, which is addressed and engaged by our staff as an essential value of our business. We commit with our Sponsors to establish, manage, and supervise its quality control and quality assurance systems and its comprehensive standard operating procedures and other quality documents to provide high quality products and services that fully satisfies the project needs

Quality is not an added Value, it’s an essential basic requierement:

• Carrying out internal audits according to regulatory standards, from early phases to post-approval, ensuring compliance with GCP (Good Clinical Practices), GLP (Good Laboratory Practices), and GMP (Good Manufacturing Practices).
• Supervision and continuous updating according to regulatory standards.
• Risk management.
• Support during external audits.