Welcome to MIRI  Clinical Research Consulting & CRO

Clinical Trials:

Phases of Clinical Trials:

Phase I: Tests the safety, dosage, and side effects of a new treatment in a small group of healthy volunteers or patients.

Phase II: Expands the study to a larger group of patients to further evaluate its safety and efficacy.

Phase III: Involves large-scale testing on diverse patient populations to confirm effectiveness, monitor side effects, and compare with commonly used treatments.

Phase IV: Post-marketing studies to gather additional information on the treatment's risks, benefits, and optimal use.

Randomized Controlled Trials (RCTs): Considered the gold standard in clinical research, RCTs randomly assign participants to either the treatment group or the control group to measure the treatment's effect objectively.

Observational Studies:

Cohort Studies: Follow a group of people over time to study the effects of certain risk factors, treatments, or diseases.

Case-Control Studies: Compare patients with a disease to those without the disease to find common exposures or risk factors.

Cross-Sectional Studies: Analyze data from a population at a specific point in time to assess the prevalence of outcomes or characteristics.

Regulatory Framework:

Ethical Guidelines: Adherence to ethical principles like informed consent, beneficence, non-maleficence, and justice.

Regulatory Agencies: Organizations such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national regulatory bodies oversee clinical research to ensure compliance with legal and ethical standards.

Data Management and Analysis:

Data Collection: Systematic gathering of data using case report forms (CRFs), electronic data capture (EDC) systems, and patient registries.

Statistical Analysis: Applying statistical methods to analyze and interpret the collected data, ensuring the results are scientifically valid and reliable.

 

Medical advice

Clinical Trial Application (CTA):

  • Purpose: To obtain authorization to conduct a clinical trial involving investigational medicinal products (IMPs) in humans.
  • Regulatory Authorities: Applications are submitted to the national competent authorities (NCAs) of the EU member states where the trial will be conducted. For France, this would be the ANSM.
  • Ethics Committee Approval: In addition to the CTA, approval from an independent ethics committee is required.

 Submissions to European Regulatory Bodies:

  • EMA Centralized Procedure: For certain types of clinical trials, particularly those involving advanced therapies, a centralized application through the European Medicines Agency (EMA) might be required.
  • Clinical Trials Information System (CTIS): Under the EU Clinical Trials Regulation (EU No 536/2014), the CTIS is the single entry point for submission, assessment, and supervision of clinical trials.

 Key Documents Required for CTA:

  • Investigational Medicinal Product Dossier (IMPD): Detailed information about the investigational product, including its composition, manufacturing, and quality control.
  • Clinical Trial Protocol: A comprehensive document detailing the trial's design, methodology, statistical considerations, and operational aspects.
  • Investigator's Brochure (IB): A compilation of clinical and non-clinical data on the investigational product relevant to its use in humans.
  • Informed Consent Form: Documents ensuring that trial participants are fully informed about the study's nature, risks, and benefits.

 Submissions to National Regulatory Authorities (e.g., ANSM in France):

  • Initial Submission: Includes all required documents such as the protocol, IB, IMPD, and consent forms.
  • Substantial Amendments: Any significant changes to the trial protocol or conduct must be submitted for approval.
  • Progress Reports: Regular updates on the trial's progress, including safety reports and interim results.

 Additional Regulatory Requirements:

  • Data Protection Compliance: Ensuring compliance with the General Data Protection Regulation (GDPR) for handling personal data of trial participants.
  • Clinical Trials Register: Registering the trial on clinical trial databases such as ClinicalTrials.gov or the EU Clinical Trials Register.

Personalised Approach and Commitment to Excellence

Our team at MIRI Clinical Research Consulting takes a personalised approach to each project, understanding that every research endeavour is unique. We are committed to excellence and go above and beyond to ensure the success of your project. Whether it's ensuring regulatory compliance or providing in-depth data analysis, we are dedicated to delivering the highest quality service to our clients.

Why Choose MIRI Clinical Research Consulting & CRO?

When you choose MIRI Clinical Research Consulting, you are choosing a team with a wealth of experience, a passion for clinical research, and a dedication to your project's success. Our personalised approach, commitment to excellence, and range of services make us the ideal partner for your clinical research projects. Let us help you bring your research to fruition and make a meaningful impact in the medical field.

Get in Touch

If you're ready to take your clinical research project to the next level, get in touch with us today. Our team is eager to discuss how we can tailor our services to meet your specific needs and contribute to the success of your project.