By Project Phase
Clinical Study Start-Up
For biotech and pharmaceutical companies, medical device manufacturers, non-profit organizations, and academic institutions that need to obtain approvals and activate study sites for clinical studies involving drugs or medical devices.
During study start-up, initial plans turn into action. From regulatory approvals to site preparation, we coordinate every step so patient enrollment can begin on time, accurately, and in full compliance with applicable requirements.
55+
Clinical studies
600 +
Investigators
300+
Hospitals
16k+
Patients
Before enrolling your first patient, are you concerned about…
- Delays in study activation that push back the date of first patient enrollment.
- Submissions to ethics committees and regulatory authorities, with different documentation requirements across countries and the risk of errors slowing down the study.
- Sites not being ready on the study start date, for example because contracts are still pending, staff have not yet been trained, or the investigational product has not arrived.
- Documents
- Contracts
- Training
- Logistics
TMF preparation and maintenance
We4 Clinical Research sets up and maintains the Trial Master File (TMF) throughout the entire study duration. The TMF serves as a comprehensive repository of essential study documents and records. We ensure that the TMF is established and maintained according to regulatory requirements, facilitating efficient document management and inspection readiness.
ISF preparation and forwarding
We4 Clinical Research supports the setup and forwarding of the Investigator Study File (ISF) to clinical sites. The ISF contains essential documents and records specific to each investigator and site involved in the study. We ensure that the ISF is properly prepared, organised, and forwarded to sites, promoting compliance and documentation integrity.
Preparation and submission of Documentation for Ethics Committee (EC) and Competent Authority (CA)
We4 Clinical Research offers support to the sponsor in determining the appropriate sample size for the study. Through the application of statistical methodologies and considering relevant factors such as effect size, power, and desired level of significance, we assist in determining the optimal number of participants needed to achieve meaningful and statistically significant results. Our expertise in sample size calculation ensures that studies are adequately powered to draw accurate conclusions.
Notification to Competent Authority (for post-market Studies with medical devices)
We4 Clinical Research can notify the Country’s Competent Authority for submission and approval of the post-market studies.
Contract Negotiation
We4 Clinical Research assists the sponsor in drafting and negotiating the Clinical Trial Agreement (CTA) with sites and other involved institutions. We ensure that the CTA reflects the study requirements, protects the interests of all parties involved, and complies with regulatory and legal considerations.
Investigators’ Meetings
We4 Clinical Research assists the sponsor in scheduling and organising Investigators’ Meetings in the early and crucial stages of the study. We contribute to creating presentations and inviting guests, facilitating effective communication and collaboration among investigators and study team members.
Good Clinical Practice and other certifications
We4 Clinical Research verifies the qualifications of investigators and supports staff by checking their credentials. We also provide guidance on obtaining and maintaining GCP Certification efficiently. We ensure that all relevant personnel involved in the study meet the necessary training and certification requirements.
Site Initiation Visit (SIV) preparation and execution
We4 Clinical Research’s staff prepares training materials and conducts Site Initiation Visits (SIV). These visits serve as an opportunity to train site personnel on study procedures, protocols, and regulatory requirements. We ensure that sites are adequately prepared to initiate the study and adhere to the necessary guidelines.
Investigational Medicinal Product (IMP) and Medical Devices (MD) Management
We4 Clinical Research can support the sponsor to manage IMP/MD throughout the study. We coordinate with distributors to ensure that research sites have the necessary investigational products for the trial. We can monitor aspects such as expiration dates, usage, and retrieval of investigational products, ensuring their proper management and compliance with regulatory requirements.
What Start-up activities include
Documents
TMF preparation and maintenance
We set up and update the Trial Master File (TMF), the archive of the study’s essential documents and records, throughout the study and in line with regulatory requirements, for orderly document management and inspection readiness.
ISF preparation and distribution
We take care of setting up and sending to the sites the Investigator Site File (ISF), the file holding the documents specific to each investigator and site, prepared and organized to support compliance and document integrity.
Documentation for the Ethics Committee and Competent Authority
We prepare and submit the documentation for the Ethics Committee (EC) and the Competent Authority (CA), to obtain the approvals needed to start the study.
European portals and requests for clarification
For drug trials we manage the application in the European CTIS portal and, for clinical investigations of medical devices, the registration in EUDAMED when required. We answer information requests from ethics committees and authorities until approval.
Notification to the Competent Authority (post-market studies with medical devices)
For studies on devices that already carry the CE mark, we prepare and send the notification to the country’s Competent Authority, in the cases where the MDR requires it.
Logistics
Management of investigational medicinal products (IMPs) and medical devices
We manage investigational products throughout the study. We coordinate distributors so that sites have the products they need and, finally, we monitor expiry dates, use and retrieval, for correct management that complies with regulatory requirements.
Contracts
Contract negotiation
We handle the drafting and negotiation of the Clinical Trial Agreement (CTA), the contract between sponsor and site, with the sites and the other institutions involved, so that it reflects the requirements of the study, protects the interests of all parties and complies with regulatory and legal aspects.
Training
Investigator meetings
We schedule and organize meetings with investigators in the early and critical phases of the study, with presentations and invitations, for effective communication and collaboration with the study team.
GCP training and staff qualifications
We check the qualifications and CVs of investigators and staff and verify that Good Clinical Practice (GCP) training is complete and up to date, so that all personnel involved are compliant before the start.
Site Initiation Visit (SIV) preparation and delivery
We prepare the training materials and conduct the Site Initiation Visits (SIVs), the start-up visits where site staff are trained on study procedures, the protocol and regulatory requirements.
Site qualification
Before activation, we verify that the staff, facilities and equipment of each site are suitable for the study, with selection visits carried out remotely or, when needed, on site.
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…
We support you in preparing and submitting the documentation to the Ethics Committee (EC) and the Competent Authority (CA). For post-market studies with medical devices, we also notify the country’s CA.
It depends on the countries involved, the number of sites, and the timelines of ethics committees and authorities. After an initial discovery call, we can outline timelines and steps for your case.
We handle the drafting and negotiation of the Clinical Trial Agreement (CTA) with the sites and the other institutions involved, so that it reflects the requirements of the study and complies with regulatory and legal rules.
We check the qualifications and credentials of investigators and staff, prepare the training materials and conduct the Site Initiation Visit (SIV), in which site staff are trained on study procedures, the protocol and regulatory requirements.
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.