Ferdoa Consult services
The goal of Ferdoa Consult is to provide you with personalized and tailored solutions, to assist you in every step of the process, to help you navigate through the challenges of clinical trials, to achieve your goals and ensure that all aspects of the clinical trials are executed with the utmost efficiency and quality..
Services Panel:
Quality Management
Assist in the development and implementation of a comprehensive quality management plan for your clinical trials and programs. Assist in the SOPs creation, update, gap analysis (where required) and training. Assist in the oversight of quality control activities to ensure that your clinical trials meet the highest standards of quality and are conducted in a manner that ensures accurate and reliable results.
Project Management
Assist in the supervision and coordination of all aspects of the clinical trial, including timelines, budget, providers involved and team members. Assist in ensuring that there is proper alignment and collaboration between the different parties involved in the trial. Assist in developing tools and reports to support the trial oversight and the reporting of the progress to the management.
Feasibility and Site Selection
Assist in the feasibility of the clinical trial to ensure that it can be successfully conducted, by assessing its ability to recruit participants and meet the protocol and regulatory requirements. Assist in selecting the appropriate clinical trial sites that are capable of performing the study and recruiting participants as planned. Assist in ensuring that the trial runs smoothly and meets its objectives.
Protocol development
Assist in developing a well-defined and consistent study protocol, which will clearly lay out the objectives, methodology, and procedures for the clinical trial. Assist in establishing a comprehensive protocol to ensure that the trial is conducted in a systematic and efficient manner.
Trial Documentation Development
Assist in developing all the necessary trial documentation for implementing the study protocol (e.g. informed consent forms and well-structured study forms and documentation, that are essential for conducting the study effectively, ethically and meet regulatory standards).
Study Files Archiving
Assist in archiving the study files and ensuring that the files are accurate, complete, and compliant with the regulatory standards. Assist in performing quality control checks on the documents and provide support in appropriately documenting any deviations or missing documentation .
Inspection Readiness
Assist in initiating and maintaining inspection readiness activities. Assist in ensuring that all aspects related to the clinical trial are complete and well documented inhouse, and at the study sites involved in the trial: study files, trial procedures, company processes, study vendors, staff training, regulatory documentation, systems compliance, handover documentation, etc.
Clinical Monitoring
Perform any type of remote or on-site monitoring visit in Spanish speaking countries and France, for any kind of protocol indication. Perform site quality visits to ensure sites are performing as per protocol. Assist in establishing some risk based monitoring measures to support quality in the clinical trial, and decrease the frequency of on-site visits, or refocus the clinical monitors during their on-site visits.
Vendors Management
Assist in the selection, setup, and management of various vendors involved in a clinical trial, such as an IRT provider, central lab, monitoring CRO, full service CRO, ECG provider, ePRO provider, etc. Assist in the finalization of the specifications, the setup of the contracts and subsequent change orders, and the invoices verification until the final budget reconciliation.
Resources & Budget Management
Assist with various aspects of clinical trial management, including resource planning (for internal and external resources) and global trial budgeting. Provide support and oversight from the initial stages of planning to the final closeout, by carefully coordinating and organizing resources, and ensuring that the study budget is allocated appropriately and efficiently.
Key Performance Indicators
Assist in defining or updating the adequate Key Performance Indicators (KPIs) for ensuring a proper oversight on the study conduct, study deliverables, company goals, budget deviations, and resource adjustments. Assist in overseeing the established KPIs, to identify potential areas for improvement or areas of concern, and propose the appropriate actions or mitigation measures.
Processes
Assist in creating or updating the necessary company and study processes, in order to ensure that they comply with the regulatory requirements. Conduct a thorough gap analysis of the existing processes to identify any areas where the current processes may fall short or do not meet the necessary standards, propose actions to bridge the identified gaps and increase the level of compliance.
Translation of study documents
Provide professional translation services for study documents, specifically subject documentation like informed consent forms and advertisement materials. Translations from English to Spanish, English to French, and vice versa. In addition, perform translation controls for the above mentioned languages, for any kind of study documentation.
Data Management activities
Review subject data and issue queries to the Clinical Research Associates or study sites. Provide support in establishing logical checks for a clinical study and creating data management manuals. Assist in writing subject narratives, and performing reconciliation between AEs/SAEs, or vendor systems involved in the clinical study, to ensure consistency, accuracy and integrity of the data.
Any other clinical trial services
Assist in a wide range of responsibilities and tasks, all aimed at supporting and facilitating the various aspects of a clinical trial, or a clinical program. Whether it is assisting from a strategic point of view, operational point of view, quality point of view or budget point of view.
