Services

Project & data management

Effective project and data management are the backbone of successful clinical research. Our approach integrates robust strategies for managing clinical studies, ensuring efficiency, accuracy, and timely delivery.

Services

Project & data management

Effective project and data management are the backbone of successful clinical research. Our approach integrates robust strategies for managing clinical studies, ensuring efficiency, accuracy, and timely delivery.

Clinical Project management

woman working on a laptop
woman working on a laptop
woman working on a laptop

Driving clinical trial success through experienced project leadership

The added value of our clinical operation team:

Serve as the single point of contact.

Serve as the single point of contact.

Serve as the single point of contact.

Provide seamless coordination across from North America to Europe and Asia.

Provide seamless coordination across from North America to Europe and Asia.

Provide seamless coordination across from North America to Europe and Asia.

Bring collaborative and multidisciplinary expertise (scientific and operational).

Bring collaborative and multidisciplinary expertise (scientific and operational).

Bring collaborative and multidisciplinary expertise (scientific and operational).

Involved and engaged in discussions from the very beginning (audit, BDM, etc).

Involved and engaged in discussions from the very beginning (audit, BDM, etc).

Involved and engaged in discussions from the very beginning (audit, BDM, etc).

Work with closely with all stakeholders, including site investigators, scientific experts, , data managers, and device managers.

Work with closely with all stakeholders, including site investigators, scientific experts, , data managers, and device managers.

Work with closely with all stakeholders, including site investigators, scientific experts, , data managers, and device managers.

Clinical project timelines

Clinical project timelines

At every step of your study, we commit to offering the highest quality of work by adapting and customizing our services to your needs, providing end-to-end clinical trial support and making sure key milestones are achieved:

Clinical Study Set-Up

Kick-off meeting.

Kick-off meeting.

Kick-off meeting.

Data protocol standardization.

Data protocol standardization.

Data protocol standardization.

Investigator site management, qualification and training.

Investigator site management, qualification and training.

Investigator site management, qualification and training.

Validation of study documentation: Project Management Plan (communication & Risk Management Plan), Review Charter, User manual, etc.

Validation of study documentation: Project Management Plan (communication & Risk Management Plan), Review Charter, User manual, etc.

Validation of study documentation: Project Management Plan (communication & Risk Management Plan), Review Charter, User manual, etc.

Clinical Study Execution

Investigator sites assistance: technical support.

Investigator sites assistance: technical support.

Investigator sites assistance: technical support.

Transversal Management: internal (between science, development, and logistics teams) and external (CRO, sponsor, vendors).

Transversal Management: internal (between science, development, and logistics teams) and external (CRO, sponsor, vendors).

Transversal Management: internal (between science, development, and logistics teams) and external (CRO, sponsor, vendors).

Data Cleaning: monitoring, quality checks and query resolution.

Data Cleaning: monitoring, quality checks and query resolution.

Data Cleaning: monitoring, quality checks and query resolution.

Central Analysis: scientific support, customized analysis and quality monitoring, management of KOLs.

Central Analysis: scientific support, customized analysis and quality monitoring, management of KOLs.

Central Analysis: scientific support, customized analysis and quality monitoring, management of KOLs.

Data Transfer.

Data Transfer.

Data Transfer.

Clinical Study Close-Out

Final database transfer & database lock.

Final database transfer & database lock.

Final database transfer & database lock.

Statistical analysis

Statistical analysis

Statistical analysis

Study closure & lessons learned.

Study closure & lessons learned.

Study closure & lessons learned.

Data archiving.

Data archiving.

Data archiving.

Our Clinical Data Management Services

Our Clinical Data Management Services

Our Clinical Data Management Services

Enhancing efficiency and integrity with centralized data management services

Effective data management is essential as we aim to enhance operational efficiency and maintain data integrity across various sectors.

By implementing robust systems and processes for collecting, storing, and analyzing data, both organizations ensure that critical information is accessible, accurate, and secure. This strategic approach enables informed decision-making, fosters innovation, and supports compliance with industry standards.

Whether it's clinical data management or data-driven insights, we prioritize maintaining a streamlined, centralized database to improve workflows, optimize performance, and ultimately provide better services to their clients.

web developers working in the dark
web developers working in the dark
web developers working in the dark

Communication and reporting

Communication and reporting

Communication and reporting

two women in conversation
two women in conversation
two women in conversation

Transparent collaboration and real-time tracking for effective oversight

A comprehensive communication plan ensures all stakeholders are informed about key milestones, deliverables, and progress. This is how we proceed:

Effective communication with the client via regular meetings.

Effective communication with the client via regular meetings.

Effective communication with the client via regular meetings.

Reporting is conducted via defined deliverables (online reports and safety reports).

Reporting is conducted via defined deliverables (online reports and safety reports).

Reporting is conducted via defined deliverables (online reports and safety reports).

Real-time project tracking is facilitated through interactive dashboards tailored to client needs,

Real-time project tracking is facilitated through interactive dashboards tailored to client needs,

Real-time project tracking is facilitated through interactive dashboards tailored to client needs,

If desired, we can support in broader communication efforts, including the co-writing of newsletters, study abstracts, and other dissemination materials.

Reach out to our team

Learn more about our clinical operations team.

Contact us

Reach out to our team

Learn more about our clinical operations team.

Contact us

Reach out to our team

Learn more about our clinical operations team.

Contact us