By Project Phase
Clinical Study Preparation
For biotech and pharmaceutical companies, medical device manufacturers, non-profit organizations, and academic institutions launching a clinical study involving drugs or medical devices.
During study set-up, we align scientific objectives, regulatory requirements, and operational workflows before the study begins, so it is straightforward to conduct and compliant from the outset.
55+
Clinical studies
600 +
Investigators
300+
Hospitals
16k+
Patients
Before starting your study, are you concerned about…
- Choosing the wrong sites and risking that they fail to enroll a single patient in your study.
- A poorly defined protocol leading to incomplete data and ongoing deviations.
- Different regulatory requirements across countries and not having the local expertise needed to manage them all.
What Set-up Activities Include
- Strategy
- Operations
- Data
- Quality
- Visibility
Protocol Review
We review every section of the protocol – the document defining the study objectives, methods and organisation – against Good Clinical Practice (GCP) guidelines, identifying inconsistencies and discrepancies before study start-up.
Preparation of Protocol Synopsis
We summarise the protocol in a clear, concise document outlining the primary objective and key study details, so stakeholders can quickly understand the study purpose and methodology.
Patient Information Sheet and Informed Consent Form
We draft or adapt the Patient Information Sheet and Informed Consent Form in accordance with local regulations and the GDPR, ensuring that patients receive clear information and Ethics Committees are provided with compliant documentation.
Sample size calculation
We determine the required number of participating patients based on effect size, statistical power and the desired significance level, so the study can generate reliable conclusions.
Statistical Analysis Plan (SAP)
Before study start-up, we work with you to define the statistical tests and analyses for primary and secondary endpoints, ensuring that study conclusions are based on methods specified in advance.
Budgeting
We estimate the resources required and calculate the per-patient fee, including recruitment, retention and compensation costs. This provides the basis for negotiating the Clinical Trial Agreement (CTA) with study sites during start-up.
Sites Feasibility and Sites Selection
We prepare and send feasibility questionnaires to potential sites and, based on their responses, select those that meet the study requirements and the characteristics you are looking for.
Local partners
In countries where a local presence is required, we select and qualify local partners by assessing their capabilities and experience against your study requirements, while remaining your single point of contact.
Laboratory and core lab selection
We select laboratories for the analysis of biosamples, imaging and other study-related materials, conducting feasibility assessments of their capacity, equipment and expertise.
Insurance set-up
We manage the process of arranging the appropriate insurance policy for your study, including liaison with brokers, quotation requests, preparation and distribution of documentation, and ongoing updates throughout the study.
Data Management Plan Design
Together with you and the Principal Investigator, we develop a plan defining procedures and guidelines for data collection, storage, validation and analysis, helping safeguard the integrity and quality of the clinical study.
Case Report Form (CRF) Design
We design a study-specific Case Report Form (CRF) that is comprehensive and easy to use.
eCRF design
We convert the CRF into an electronic Case Report Form (eCRF) within the EDC platform, incorporating automated edit checks that flag missing or inconsistent data at the point of entry.
Randomisation List generation
For randomised studies, we generate customised randomisation lists and define stratification factors and block sizes to support random and unbiased allocation to study arms.
Data Safety Monitoring Board (DSMB) or Clinical Events Committee (CEC)
We draft the committee charter—the document defining its procedures—and organise meetings on behalf of the sponsor, supporting appropriate oversight of participant safety and study integrity.
Monitoring Plan
We define the monitoring strategy best suited to your needs and prepare the plan specifying visit frequency and procedures, supporting effective oversight and compliance with the protocol and regulatory requirements.
Quality Plan
We define quality control and quality assurance strategies and procedures for the entire study, helping maintain the integrity and credibility of the results.
Risk management (RBQM)
We identify the factors that are critical to study quality and develop a risk management plan to guide monitoring and oversight activities, in line with the GCP risk-based approach.
Kick-Off Meeting and Investigators’ Meetings
We organise kick-off and investigator meetings, key opportunities for communication and alignment among stakeholders, including agenda preparation, presentations and invitations.
Study website and social media channels
We create a dedicated study website and promote it through social media, using recruitment materials submitted to the Ethics Committee, to engage potential participants and stakeholders and support both patient recruitment and retention.
Registration of the study on clinicaltrials.gov
On behalf of the sponsor, we manage study registration on ClinicalTrials.gov, submitting study information and required updates to make the study publicly accessible to the scientific community.
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 have conducted over 55 clinical studies, involving more than 300 hospitals and 600 investigators. The quality management system of We4 Clinical Research for the conduct of clinical studies is ISO 9001:2015 certified, and our processes are aligned with ICH GCP and, for medical devices, with ISO 14155. Every study is followed by a dedicated team: the same people from start to finish.
We send feasibility questionnaires to potential sites and, based on the responses received, we select those that meet the requirements of the study and the characteristics you are looking for.
With a single team combining clinical and regulatory activities there are fewer handovers: if the protocol changes, the people running the study and those handling the regulatory side already work together to rebuild the context of the project.
It depends on the type of study, the indication, and the number of sites and countries involved. After an initial discovery call, we can outline timelines and steps for your case.
Absolutely. Our services are flexible and modular: you can start with Set-up and add other phases to your study when you need them, or entrust us with the study from protocol to close-out. Discover all our CRO solutions.