Clinical Research Agency: the CRO for clinical trials management
-Your partner for clinical trials-
Our mission is to help you successfully manage your clinical trials as a Contract Research organization.
We bring unparalleled expertise and extensive experience to the world of clinical trials management.
We provide high-quality, cost-effective, and tailor-made solutions to our clients, while maintaining ethical standards and regulatory compliance.
We also aim to foster long-term relationships with our sponsors, researchers and sites, to contribute to the advancement of medical science and patient care.
Full-service CRO: solutions for Biopharma
We offer a wide range of high-quality clinical trial services, tailored to the needs and goals of each client, making them accessible to all.
Our services cover all stages of clinical development, from design to reporting, management and monitoring.
We accompany and advise you the whole way.
Our collaboration with biopharma companies goes beyond traditional CRO services.
We consider ourselves an extension of your team, working closely with your researchers, scientists, and project managers to ensure seamless communication and a shared vision.
Our professionals with expertise in different therapeutic areas ensure compliance with ethical and regulatory standards.
Clinical trial Management
We coordinate and supervise all activities related to clinical trials, from start-up to close-out.
That includes obtaining the necessary permits and authorizations, managing supplies and materials, communicating with sites and researchers, resolving incidents, preparing periodic reports and prioritizing quality and data credibility; it’s all in our hands.
Start-up
We manage all the steps involved in obtaining clinical trial authorization and approval from organizations such as AEMPS and have extensive experience with CTIS.
We also report to the competent authorities and ethics committees, acting as point of contact and/or authorized representative, depending on the client's needs.
Clinical trial monitoring
At Clinical Research Agency, we are flexible with our clients’ needs regarding visits and can cover all monitoring actions, from feasibility, site initiation visit (SIV), monitoring visit (MV), to the close-out visit, whilst following the highest quality standards.
Our CRAs are focused on achieving the highest data quality and adhering to GCP.
Depending on the study/client and their needs, we can perform periodic visits to the sites participating in the clinical trial to verify compliance with the protocol, data quality, subject safety and facility adequacy.
Clinical Trials management: Why choose us as your partner
Our team will provide tailor-made solutions that follow the regulatory quality standards to meet your specific requirements and make your clinical trial more efficient and reliable.
We find the best options for launching your clinical trial and secure all the necessary documentation from the AEMPS, CTIS and government bodies.
Passionate about improving health, we have assembled the best team in the business, whose talent, attention to detail and involvement are our formula for unbeatable results.
Trust
Trust fuels discovery and innovation.
Quality
Quality is at the heart of everything we do.
Trust
Trust fuels discovery and innovation.
Flexibility
Tailor-made solutions for every stage of the project.
Speed
Efficiency and speed are our main priorities.
Quality
Quality is at the heart of everything we do.
Unlocking new worlds and bringing your ideas to life
We are committed to helping biopharma companies offer life-changing therapies to the world. Our dedication and proficiency drive us to excel in every aspect of clinical research.
At Clinical Research Agency, we firmly believe that every clinical trial has the potential to advance medicine and change lives.
Due to the constant changes in legal regulations and processes, we follow developments and news very closely so your clinical trials run smoother.
We are passionate about the work we do and the impact it has on patients and healthcare.
Be part of the change: the new era in medicine
Let's change the world of healthcare together, one clinical trial at a time
Have any questions or want to work with us? Our team is on hand to answer your queries and discuss how we can support your clinical research goals.
Let's connect and collaborate.
Regulatory Consulting for Clinical Trials in Spain
In the competitive and regulated world of clinical research, regulatory consulting for clinical trials in Spain is essential to ensure compliance with regulations and the proper execution of studies. Consulting agencies specialized in clinical trials provide comprehensive guidance for the design, implementation, and monitoring of trials, ensuring that all local and international regulations are efficiently met.
This type of service is fundamental for companies and organizations wishing to conduct clinical trials in Spain, ensuring that every step is carried out according to the guidelines of the Ministry of Health and the Spanish Agency of Medicines and Medical Devices (AEMPS).
CRO in Spain with AEMPS Experience
CROs in Spain (Contract Research Organizations) with AEMPS experience are essential for facilitating the regulatory process of clinical trials. These organizations provide full support for clinical trial management, from planning to execution, helping to ensure compliance with the requirements established by the Spanish Agency of Medicines and Medical Devices.
Phase I Clinical Trials in Spanish Hospitals
Phase I clinical trials are mainly conducted in hospitals, where the safety and tolerance of an experimental drug or treatment are evaluated. Regulatory consulting for clinical trials is crucial during this phase, as the AEMPS approval process and ethical oversight must be managed properly to minimize risks.
CEIm Consulting for Ethical Approval
One of the cornerstones of conducting clinical trials in Spain is obtaining ethical approval from the Ethics Committees for Clinical Research with Medicines (CEIm). CEIm consulting is fundamental to ensuring that the study is carried out to high ethical standards, protecting the rights and well-being of the participants.
Outsourcing Clinical Trial Monitoring
Clinical trial monitoring is a key process to ensure the quality and integrity of the data collected during a study. Outsourcing this service to experts in the field allows sponsors to focus on other areas of the trial, knowing that clinical supervision is being carried out in accordance with AEMPS regulations and Good Clinical Practice (GCP).
Patient Recruitment for Clinical Trials in Spain
Patient recruitment is one of the most critical stages of any clinical trial. For a trial to be successful, it is essential to have patients who meet the specific requirements and are willing to participate in the study. Regulatory consultancies with experience in patient recruitment for clinical trials in Spain have established networks and effective strategies to attract the right patients.
GCP Audit for AEMPS Inspection
GCP (Good Clinical Practice) audits are essential to ensure that clinical trials are conducted in accordance with international and local regulations. A GCP audit carried out before an AEMPS inspection can help identify potential deficiencies and correct them before they become issues.
Protocol Optimization for CEIm
The clinical trial protocol is a key document in any research study. Protocol optimization for CEIm is essential to ensure that the study meets the necessary ethical and regulatory requirements for approval. Regulatory consultancies can help improve the clarity and structure of the protocol, reducing the likelihood of rejections or delays by ethics committees.
Consulting for Ethics Committees in Spain
Engaging with Ethics Committees is a fundamental aspect of managing clinical trials. Consulting for ethics committees in Spain ensures that the study is reviewed from an ethical perspective, safeguarding participant safety and trial integrity. The consulting process also includes preparing the necessary documentation and following up on the ethical approval process.
