By Project Phase
Clinical Study Conduct
For biotech and pharmaceutical companies, medical device manufacturers, non-profit organizations, and academic institutions conducting clinical studies involving drugs or medical devices that need to monitor progress, maintain reliable data, and remain compliant.
Once the study is underway, precision and adaptability become critical. We monitor progress, safeguard data integrity, and keep all stakeholders informed to ensure the study remains compliant, stays on schedule, and is ready to adapt when changes arise.
55+
Clinical studies
600 +
Investigators
300+
Hospitals
16k+
Patients
While your study is ongoing, are you concerned about…
- Incomplete or inconsistent data that only comes to light at a later stage of the study.
- A lack of transparency from your CRO and not knowing where the study really stands.
- Every protocol amendment costing time and money due to new approvals and documentation updates.
- Documents
- Data
- Monitoring
Notification of First Enrolment to the EC/AC
We4 Clinical Research can notify the Ethics Committee (EC) and/or Competent Authority (AC) about the first enrolment of the study. This notification ensures that the relevant regulatory bodies are informed and updated on the study’s progress.
Amendments to study documentation
We4 Clinical Research manages protocol amendments to facilitate their speedy approval and implementation. Our team updates the required documentation and ensures that the amendments align with regulatory guidelines and study objectives.
Newsletters
We4 Clinical Research prepares and distributes newsletters to communicate updates on the study’s progress. These newsletters serve as a means to highlight relevant updates, share significant milestones, and keep all stakeholders informed and engaged.
Interim Report
We4 Clinical Research has the capability to generate and review interim reports for the study. These reports provide a snapshot of the study’s progress, including key findings, data trends, and any necessary recommendations for adjustments or improvements.
Data Management & Cleaning
We4 Clinical Research provides comprehensive data management services throughout the study. This includes effective tools and processes for data cleaning, ensuring the accuracy and consistency of the study data. We employ robust data management practices to maintain data integrity and facilitate data analysis.
Remote Data Entry Verification
We4 Clinical Research ensures that data entry is conducted accurately and efficiently, adhering to established protocols and guidelines, via periodic gap analyses and consistency checks; it represents a fundamental step that assures a continuous overview throughout the study and guarantees a proper preparation of the data for interim statistical analysis and monitoring visits.
Remote and on-site Monitoring Visits
We4 Clinical Research conducts monitoring visits either remotely or on-site to ensure the study’s proper execution. These visits are performed in accordance with the protocol, monitoring plan, Good Clinical Practice (GCP), and relevant principles. We monitor study activities, data quality, and compliance with regulatory requirements.
Investigator Meetings
We4 Clinical Research assists the sponsor in scheduling and organising Investigators’ Meetings during the study progress, if deemed worth by the sponsor. We contribute to creating presentations and inviting guests, facilitating effective communication and collaboration among investigators and study team members.
What Development activities include
Documents
Notification of first enrollment to the competent authorities
We notify the first enrollment to the Ethics Committee (EC) and the Competent Authority (CA), keeping the relevant regulatory bodies updated on the progress of the study.
Amendments to study documentation
We manage protocol changes and update the required documentation, to support timely approval and keep it aligned with regulatory guidelines and the objectives of the study.
Study newsletters
We prepare and send newsletters on study progress, to share updates and key milestones, keeping all stakeholders informed and engaged.
Interim reports
We generate and review the interim study reports, giving a snapshot of progress with the main results, data trends and recommendations for any adjustments.
Safety
Safety management plan
We define workflows, responsibilities and reporting timelines for safety events from the start of the study.
Adverse events and device deficiencies
We collect and follow up over time adverse events (AEs), serious adverse events (SAEs) and, in device studies, device deficiencies (DDs), with the medical review of our Medical Director.
Reporting to authorities and ethics committees
We handle the reports required within regulatory timelines, including SUSARs and the annual safety report (DSUR) for drug trials, and MDR vigilance for devices.
Data
Data management and cleaning
We manage data throughout the study, with tools and processes for data cleaning, maintaining data accuracy, consistency and integrity to facilitate analysis.
Remote data entry verification
We remotely verify that data have been entered accurately and according to the protocol, with periodic gap analyses and consistency checks, for continuous visibility over the study and data ready for interim statistical analyses and monitoring visits.
Interim analyses and DSMB
We prepare the interim analyses and the tables for the meetings of the Data Safety Monitoring Board (DSMB), when required by the protocol.
Monitoring
Centralized monitoring and site visits
We continuously analyze eCRF data remotely and schedule monitoring visits, remote or on site, where risk requires it, in line with the protocol, the monitoring plan and Good Clinical Practice (GCP).
Investigator meetings
We schedule and organize meetings with investigators during the study, whenever you see fit, with presentations and guest invitations, for effective communication with the study team.
The We4CR Method
What guides us
Risk-based
Controls and resources always proportionate to the risk of each study.
Patient Centric
Studies designed around patients’ needs.
Quality over quantity
The rigor of our work comes before the numbers.
What you get in every study with We4CR
Tools developed by the We4 group support decentralized trials and operational flexibility, driving speed and quality without compromising compliance.
Site selection strategies and patient engagement tools help reduce recruitment delays and dropouts, containing cost overruns and making time-to-market more predictable.
Our digital solutions turn patients into active participants in the study, supporting retention and protecting the sponsor’s investment.
Services tailored to your study
Our flexible, modular way of working adapts to each sponsor’s operating model, so resources are used efficiently.
We build flexible, on-demand teams calibrated to the needs of each project, matching resources and expertise to the complexity of the study and its therapeutic area.
The same people follow your study from start to finish, with no internal handovers and a single point of contact who knows the whole history of the project.
We work with qualified local consultants when the project requires it.
Studies conducted
studies on medical devices
studies on drugs
International presence
European Union
7 countries
Non-EU countries
8 countries
People also ask…
Study newsletters on progress and milestones, together with interim reports, give a snapshot of progress, main results, data trends and recommendations for the study.
At We4CR we manage protocol changes and update the required documentation, to support timely approval and keep it aligned with regulatory guidelines and the objectives of the study.
We do it through data management and cleaning throughout the study, remote verification of data entry, periodic gap analyses and consistency checks.
Yes, we notify the first enrollment to the Ethics Committee (EC) and the Competent Authority (CA).
Absolutely. Our services are flexible and modular: you can add other phases to your study if you need them, or entrust us with the study from protocol to close-out right from the start. Discover all our CRO solutions.