Clinical studies are crucial to the process of bringing a new product to market, whether it is a Medical Device,Biotech product or Pharmaceutical. Conducting aclinical trial in an ethical and appropriate manner is a key factor to ensuring asuccessful regulatory submission and later on, the sales process.
We cover a wide range of clinical services according to the applicable standards and regulations (including ICH-GCP, ISO 14155, Israeli MoH guidelines, MDR and FDA CFRs).
Our team has extensive experience in various therapeutics areas* from early stages through pivotal studies and PMS
Our services includes:
Clinical Trial Preparation
The CIP shall clearly outline the objectives of the clinical investigation. The proposed design shall be adequately justified based on scientific and ethical principles.
Together with our Clinical writing group and collaboration with the medical team at your company we develop and can write the Clinical investigation Plan for your study and based on acceptable templates.
HaMaDa experts can take care of the preparation of a Literature Review using the experienced hands of our CLINICAL WRITING team.
The purpose of the IB is to provide the principal investigator and the investigation site team with sufficient safety or performance data from pre-clinical investigations or clinical investigations to justify human exposure to the investigational device specified in the CIP.
HaMaDa CLINICAL WRITING team can assist with the preparation of your Investigators Brochure.
The sponsor shall identify criteria necessary for the successful conduct of the clinical investigation prior to start of the site qualification process, including the facilities required at the clinical investigation site, principal investigator’s qualification and the type of environment. All these are critical to the success of the study.
A visit to assess the ability of the site and the experience of the investigators are highly important.
The principal investigator or his/her authorized designee shall comply with the general process for obtaining informed consent. This document should be clear and simply phrased for the subject’s to comply with the local guidelines. This document is thoroughly reviewed by the ethical committees.
According to the Israeli MoH guidelines, it is required to submit a package of forms to the institutional ethical committee. We have vast experience in preparing the packages in collaboration with your company and the site study coordinator.
The CRFs shall be developed to capture the data for each enrolled subject as required by the CIP. The CRFs shall include information on the condition of each subject upon entering, and during the course of the clinical investigation, exposure to the investigational device and any other therapies.
An Electronic Data Capture (EDC) system is software that’s used to electronically collect, manage and store clinical research trial data. This data gets collected, uploaded and saved in an electronic Case Report Form (eCRF). EDCs can either replace or back up traditional paper-based methods of data collection.
EDC systems make it easier and promote success by offering accuracy, compliance and safety.
The sponsor shall determine the extent and nature of monitoring appropriate for the clinical investigation based on the risk assessment.
The extent and nature of the monitoring, including the strategy for source data verification versus centralized data review (evaluation without visiting the investigation site), subject protection and timely reporting, shall be based on the objective, design, complexity, size, critical data points and endpoints of the clinical investigation and the degree of deviation from normal clinical practice – risk-based. monitoring.
An initiation visit for each participating investigation site or, alternatively, an investigator meeting shall be conducted and documented by the sponsor or monitor at the beginning of the clinical investigation.
The monitor shall initiate each investigation site in accordance with the monitoring plan to ensure that the principal investigator and investigation site team have received and understood the requirements and contents of the CIP, IB, ICF, CRFs, IFU, any written clinical agreement, have been trained in the use of the investigational device and are familiar with the responsibilities of the principal investigator.
Clinical Trial Conduct
The conduct of the clinical investigation shall be monitored according to the monitoring plan. Please bullet preparation of monitoring plan.
Safety evaluation and reporting are the responsibilities of the Sponsor and principal investigator. The CRO will verify that all safety issues are indeed reporting appropriately and will help with the collection of the documents , reporting to the ethical committees and annual/semi-annual reporting to the regulation authorities as required.
Site management that is done on n ongoing base during the study by the project manager of the CRO and study CRA.
Clinical Trial Closure
Routine close-out activities shall be conducted to ensure that the principal investigator’s records are complete, all documents needed for the sponsor’s files are retrieved, remaining clinical investigation materials are disposed of, previously identified issues have been resolved, and all parties are notified.
HaMaDa team of expert Medical and Clinical Writers can serve your company by preparing a professional Clinical Study report.
For the preparation of your publication, to meet the appropriate requirements coming from the chosen Peer reviewed Magazine, please refer to our Medical / Clinical Writing team.
General Clinical Management – for companies that do not have a clinical team or enough experience to manage their studies we offer comfortable conditions to manage their clinical activities.
*Therapeutic Areas- Treatment and Diagnostic Devices
Cardiovascular, Endocrinology & Metabolism (Diabetes, Osteoporosis), Urology, Infectious diseases, Ophthalmology, Gynecology, Musculoskeletal, Neurology, Neurosurgery, Dentistry, Plastic Surgeries, Esthetics, Pain, Pediatrics, Neonatology, Oncology, Orthopedics, Respiratory, Esthetics
