We are focused on developing and commercialising products to treat or prevent gastrointestinal disorders and improve endoscopy performance. Our clinical trials are designed to the highest scientific and clinical standards. All clinical trials procedures follow a set of standards to protect the rights, dignity, safety and well-being of clinical trial research participants.
All R&D employees receive training in relation to ICH Good Clinical Practice (GCP) guidelines; Good Distribution Practice (GDP) guidelines and medical device guidelines.
Designing a clinical trial project
All projects are thoroughly planned and designed to prevent malpractice, misconduct or breaches of personal data and confidentiality. When designing a study protocol our priority is to ensure that the potential benefits to the patient and to society is in proportion to the inherent risk and burden to the research participants. To achieve these goals, we leverage the expertise of Key Opinion Leaders (KOLs) in each different therapeutic area, who collaborate with us in designing the clinical studies in line with the current best clinical practice in the field.
Employees of Cosmo involved in Clinical Research are required to:
- Familiarise themselves with the principles of ICH-GCP for drug products and/or ISO14115 for medical products;
- Collaborate with the KOLs in the field to design and develop the protocol to ensure it aligns with current best clinical practice;
- Create a clear, detailed and concise study protocol, study design and related study materials such as: study worksheets, study training presentations etc;
- Seek for review and agreement of the study protocol with the relevant regulatory agencies for late-stage studies intended to support the registration of products;
- Conduct trials in compliance with the approved protocol/favourable opinion received from the Institutional Review Board (IRB); Independent Ethics Committee (IEC);
- Adhere to robust and ethical principles.
Protecting our clinical trial research patients
We require a signed voluntary informed consent form for all participates in clinical research prior to the commencement of any study related procedures. We design informed consent forms which specify the known benefits and the risks associated with participation in each trial using clear and simple language which can be easily understood by study participants.
To protect clinical trial participants, we adhere to applicable national and international regulations and guidelines such as the Declaration of Helsinki, ICH Good Clinical Practice (GCP) Guidelines; Good Distribution Practice (GDP) guidelines and ISO guidelines.
The Clinical Research Team are requested to:
- Adhere to all local legislation and international guidelines for the process of obtaining informed consent.
- Ensure that informed consent forms have received a favourable opinion/approval from the Institutional review board (IRB); Independent ethics committee (IEC), as applicable;
- Ensure that investigational sites follow Good Clinical Practices (CGP), thoroughly explain the study design, possible benefits and foreseeable risks and ensure that an informed consent form is signed by each study participant.
Safety Monitoring
We ensure that patients enrolled in our trials are appropriately monitored during the clinical trial and follow-up periods. All adverse event information is collected, processed, reported, analysed and is submitted to the relevant competent authorities as per national and international requirements. We engage experienced Medical Monitors in our studies, who are responsible for providing medical expertise and oversight for the entire clinical trial, from initial study design through final study close-out. Medical Monitors are responsible for monitoring all the medical aspects of the study, including the evaluation of safety issues. The Medical Monitors collaborate with the investigational sites and principal investigators in the assessment of serious adverse events and may trigger study hold-on periods in case of safety issues potentially affecting the well-being of the patients.
It is essential that all employees involved in Clinical Research:
- Monitor the safety of the investigational products or devices and ensure that appropriate reporting processes are in place;
- Establish and maintain the relationship with the investigational sites, and ensure that the study procedures and safety assessments are followed per protocol;
- Ensure that, following serious adverse events, a proper investigation is performed to ascertain the possible causes and to establish the relationship between the event and the investigational drug or device;
- Review and update investigational product or device brochures or development reports on a yearly basis (or as required per national or international guidelines).
- Ensure reporting of any Suspected Unexpected Serious Adverse Reactions as per the national and international guidelines.
Outsourcing Monitoring Activities
Cosmo is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted, and data is generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirements.
Cosmo may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with Cosmo.
It is the duty of all members of the Clinical Trial Team to:
- Follow the clinical trial monitoring SOPs and clinical trial oversight requirements;
- Ensure that the selected CRO has appropriate SOPs in place for the management of the clinical trial, which are in line with the current national and international quality standards;
- Keep constant communication with the selected Clinical Research Organizations (CROs) and ensure a good conduct of the clinical trial;
- Conduct oversight clinical monitoring visits as per the SOP requirements;
- Review the clinical data on ongoing basis and escalate, correct and prevent any pertinent issues that might have an impact on the clinical trial conduct and patient safety.