What we do
CLASSIFICATION AND EVALUATION OF A MEDICAL DEVICE
We offer the best solutions for classification, evaluation, and registration of a medical device before a trial is started to establish applicable requirements.
CLINICAL TRIAL PROTOCOLS
We draft and verify clinical trial protocols in cooperation with our medical consultants and statisticians. We are experienced and trained to prepare clinical research documentation. Protocols drafted by us not only allowed collection of critical safety data but were also approved by Bioethics Committees with minor corrections. Investigators working with us found our protocols clear, unambiguous, and easy to follow, which translated to high quality performance of the study team. Preparation of every protocol is completed with a meeting of the medical consultant, project manager, and statistician, who also evaluate the project risk and prepare risk mitigation measures.
DOCUMENTATION FOR CLINICAL RESEARCH
We prepare and develop documents necessary to conduct a clinical trial, such as:
– Investigator’s Brochure
– Patient’s/Participant’s Informed Consent Form
– Case Report Forms (CRFs)
– Questionnaires and patient’s/participant’s diaries
– Project management plans, i.e. patient recruitment plan, monitoring plan.
Thoroughly developed and designed documentation facilitates a correct process of obtaining the approval to open a trial. Our highly qualified staff draft documents, which are concise and compliant with regulations in force, allowing no delays in clinical trial commencement.
MONITORING OF CLINICAL TRIALS
Clinical research monitoring is done according to the Helsinki Declaration, Good Clinical Practice standards as well as requirements specific for a country.
Trial monitoring covers the following:
• Site initiation visits, monitoring visits, and close-out visits
• Regular, on-going training for the site personnel during a trial
• Organizing meetings with investigators
• Preparation of the Trial Master File (TMF) and Investigator Site File (ISF)
• Preparation of sites for audits and inspections
• Regular contacts with the sites between visits – remote monitoring
• Clearing of payments for the sites
• Assistance visits to ensure quality of the data and high standards of performance from the site personnel
• Project management.
We provide coordination and integration of all the activities related to running a project according to the agenda within the agreed budget as well as efficient project communication among all the parties involved. Project managers are in charge not only of project progress evaluation but also monitoring and risk management.
We ensure accurate and timely data monitoring and regular reports submitted to the study sponsor.
MONITORING OF CLINICAL TRIALS
There are three main groups among medical devices: medical devices, medical devices for in vitro diagnostics and active medical devices for implantation. In view of the risk related to medical devices they are divided into four classes: I, IIa, IIb, and III, where class I devices present minimal risk, class II – moderate risk, and class III – high risk.
As a CRO we support manufacturers of medical devices in conducting clinical trials. We render services in qualification and clinical evaluation of a device and CE marking.
We are experienced in running observational studies, e.g. prospective and retrospective studies, patient’s treatment evaluation forms. We prepare a plan for project execution, agenda, tools to collect the required data as well as offer cooperation with reliable sites to run this type of projects. Additionally, we offer verification of the gathered data to be performed remotely or on the site.
SELECTION OF FEASIBILITY SITES
We cooperate with a range of reliable sites, which provides high quality of clinical data, patient recruitment according to the plan, and accelerated site start-up.
At the same time, we have our own database for sites and investigators, which is developed on an on-going basis.
Our clients are offered complete analysis of a clinical trial feasibility. We select the sites very carefully, so they are perfectly matched for a project execution. We guarantee that all the sites we select will be able to recruit the expected number of patients/participants, have adequate resources and equipment necessary to complete a trial and the investigators present relevant experience in conducting clinical research.
We prepare complete documentation required to be submitted to a Bioethics Committee and the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
We also assist in obtaining the necessary civil liability insurance for investigators and sponsors.
EARLY PHASE STUDIES
For many years we have been working with phase 1 sites, which undergo regular inspections run by the bodies supervising marketing of medical devices. We run trials, where a medicinal product is administered to volunteers for the first time according to the Single Ascending Dose (SAD) design and Multiple Ascending Dose (MAD) design.
We provide on-going safety monitoring performed by Medical Consultants, who are a part of the Safety Review Committee together with the involved investigators. Owing to prompt site start-up and detailed planning we guarantee conducting a trial according to a precisely developed agenda. Apart from the phase 1 research with healthy volunteers we also run early-phase trials to establish the dose of a study drug in oncological and rare diseases in adults and children.
Emphasis on the quality of clinical research is aimed mostly at providing safety for all the patients involved and obtaining reliable and thorough data.
In relation with quality assurance we offer:
• Training for site personnel on audits and inspections
• Site audits, e.g. before expected inspections or related to low quality data provided by a site (audits for cause)
• Internal audits
• Evaluation and improvement of the Quality Management System
• Development of Standard Operating Procedures.
Pharmacovigilance & Medical Monitoring
STATISTICAL AND CLINICAL REPORTS
E-mail or call us, whenever you get interested in our services and solutions!
GENELYTICA SP. Z O.O.
Tel.: +48 737 486 824
ul. Akademicka 48A