International Clinical Research Group With The Focus on Medical Monitoring
Development Phases and Expanded Access Programs
At Saberg Clinical Research, we support phase I (e.g., first-in-human, first-in-patient, proof-of-pharmacology), phase II (e.g., proof-of-concept, dose-finding, drug-drug interaction, etc), phase III (registration) and post-marketing clinical trials. We also provide support for the Expanded Access/Compassionate Use Programs.
Our scientific team provides an integrated approach to drug development. This approach begins with helping the Sponsor determine the next research step based on the data collected to date. We also help design innovative, tailored clinical trials (including biostatistics, clinical pharmacology, site selection and/or core lab selection). A properly designed trial also helps the Sponsor minimize costs, which is an importance consideration, particularly in the early development phase. As needed, we can draw upon our vast network of highly experienced and high-profile key opinion leaders by organizing meetings with the Sponsor and establishing a scientific advisory board.
Medical Monitoring is the core of our activities. Either as stand-alone or acting as Medical Directors for a Sponsor that outsources the medical team, we provide the full range of services. Throughout the clinical trial or expanded access/compassionate use program, our medical team performs periodic reviews of the emerging data and can perform round-the-clock medical monitoring, which is essential to the success of a development program. Our medical monitors confirm the subjects’ eligibility, evaluate the medical data collected during the trial (medical history, concomitant medications, vital signs, physical examinations, lab results, ECG, specific imaging, etc.), supervise all trial-related medical procedures, evaluate any adverse events, and serve as a liaison between the Sponsor and the research site’s medical staff.
In the early phase of drug development, it is often beneficial to establish a Data and Safety Monitoring Board (DSMB) to independently monitor the safety of the trial participants. At Saberg Clinical Research, we have considerable experience selecting, organizing, and managing DSMBs. In addition, based on the study protocol we can also establish and manage a Clinical Endpoint Committee (CEC), and we can manage the flow of data for the CEC’s members. At the end of the trial, our medical monitors will work closely with the Sponsor to prepare, review, and finalize the clinical study report.
The medical monitors work closely with the pharmacovigilance specialists. They are responsible for the registration of the Sponsor with the EudraVigilance (EV), registration of the new compound into the EudraVigilance eXtended Medicinal Product Dictionary (XEVMPD), adverse events case processing including causality and expectedness assessments and adverse events expedite reporting to the national competent authorities, the EV and when necessary to other international authorities such as the US FDA, Health Canada etc. Case narratives are written for serious adverse events, events leading to drug discontinuation and other events of special interest. We also prepare and/or review the development safety update report (DSUR), SUSAR line listings and other periodic reports (when required), as well as the Investigator's Brochure.
Our medical monitors help prepare the study protocol and other critical documents (eg Informed Consent Forms) and ensure that all local requirements are properly addressed, thereby increasing the likelihood that the regulatory bodies and ethics committee will approve the program. We prepare other documents, including the medical monitoring plan, and the safety reporting plan. At the end of the trial, our medical writers will work with the Sponsor to prepare, review, and finalize the clinical study report.
We conduct clinical research in the following fields:
Rare and ultra-rare (i.e.,orphan) diseases