Phase I - phase III international clinical research group
We design and conduct clinical research in the following fields:
Rare and ultra-rare (i.e.,orphan) diseases
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), and phase III (registration) clinical trials. For first-in-human and proof-of-pharmacology trials, we work closely with state-of-the-art facilities in the Netherlands. For first-in-patient and bio-equivalence trials, we work with various facilities in various countries. Our phase II and III trials are conducted in hospitals and clinics around the globe.
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 can also design an innovative, tailored clinical trial (including biostatistics, clinical pharmacology, site selection and/or core lab selection), obtain regulatory approval, and provide medical writing to maximize the likelihood of completing a successful clinical trial. 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.
Throughout the clinical trial, 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 clinical trial. Our medical monitors confirm the subjects’ eligibility, evaluate the medical data collected during the trial (e.g., medical history, concomitant medications, vital signs, physical examinations, lab results, ECG, 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 writers will work closely with the Sponsor to prepare, review, and finalize the clinical study report.
The pharmacovigilance specialists work closely with the medical monitors. 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 submit the development safety update report (DSUR), SUSAR line listings and other periodic reports (when required) to all regulatory bodies involved in the trial.
We also offer a broad range of pharmacovigilance (drug safety) services for the market authorisation holders (MAHs).
Our medical writers prepare the study protocol and ensure that all local requirements are properly addressed, thereby increasing the likelihood that the regulatory bodies and ethics committee will approve the protocol. We can also prepare all other documents, including the informed consent form, 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.
Our team of medical writers can also write the DSUR and can update the Investigational Brochure.
At Saberg Clinical Research, we provide a comprehensive set of clinical operations that are customized to the needs of each trial while adhering to all Good Clinical Practice (GCP) requirements. Study feasibility and site selection are optimized thanks to our vast network of research sites. During pre-study assessment, we meet with the investigators to thoroughly discuss the study design and any possible challenges with respect to subject recruitment.
Before beginning the local submission procedures, we consult with regulatory experts regarding recent changes in the procedure and the submission requirements. Throughout the entire procedure, the study team closely follows each step, ensuring that all relevant documents are in order and rapidly facilitating agency approval.