Full-Service Clinical Trial Support - Key Areas
Early phase clinical development is the first stage of the clinical trial process for a new drug or therapy. During this phase, the drug or therapy is tested in a small group of healthy volunteers or patients to determine its safety, dosage, and efficacy. The primary objectives of early phase clinical development are to evaluate the safety of the drug or therapy, determine the optimal dosage and assess the efficacy of the drug or therapy.
Early phase clinical development typically involves a small number of participants, usually fewer than 100, and the trial may last a few months to a year. The results from early phase clinical trials are used as basic for the design of later-phase clinical trials, which involve larger groups of participants and provide more extensive safety and efficacy data.
Medical device clinical investigations are studies conducted to evaluate the safety and efficacy of medical devices before and after they are marketed and made available for clinical use. These investigations are conducted to gather clinical evidence to support the safety, performance, and benefits of the medical device.
The process of conducting a medical device clinical investigation typically involves several stages from First-in-Human, feasibility studies up to post-marketing follow-up (PMFC) evaluation. Our experience includes studies of all types related to medical devices of different classes, in vitro diagnostics devices (IVD) or digital devices.
Non-commercial investigator-initiated trials (IITs) are clinical trials that are proposed, designed, and implemented by individual researchers or research institutions, rather than by commercial sponsors such as pharmaceutical companies. These trials are initiated and funded by academic researchers, medical professionals, or non-profit organizations.
The purpose of IITs is to generate scientific knowledge in areas where there is limited research, without any commercial interests or profit motives. They may focus on testing new drugs, devices, or treatments, or evaluating existing ones in new patient populations or for new indications.
Full-Service Clinical Trial Support - Key Areas
We provide services in clinical development field, having experience in main therapeutic areas spanning from oncology and hematology through cardiology, neurology, respiratory up to rare diseases. Our expertise cover full service delivery of the clinical project, but our main focus falls on early phase clinical trials, medical device studies and investigator Initiated Trials.
Full-Service Clinical Trial Support
Full-service clinical trial support within the European Union represents a comprehensive and integrated approach to managing all aspects of a clinical trial, from initial protocol development to final clinical study report submission. This model aims to streamline the process, enhance efficiency, and ensure compliance with the complex regulatory landscape of the EU.
The cornerstone of full-service support is a deep understanding of the Clinical Trials Regulation (CTR), which has harmonized clinical trial procedures across member states. This necessitates expertise in navigating the Clinical Trials Information System (CTIS), ensuring timely submissions, and adhering to strict timelines. Furthermore, compliance with the General Data Protection Regulation (GDPR) is paramount, requiring robust data management systems and meticulous attention to patient privacy.
Full-Service Clinical Trial Support
Full-service support encompasses a wide array of activities. This includes protocol development, which requires a thorough understanding of scientific rationale and regulatory requirements. Feasibility studies are conducted to assess patient populations, site availability, and logistical considerations. Site selection and management involve identifying suitable investigators and facilities, ensuring adherence to Good Clinical Practice (GCP) guidelines.
Patient recruitment is a critical component, requiring strategic planning and execution to meet enrollment targets. Effective patient management involves ensuring adherence to study protocols, monitoring adverse events, and maintaining patient safety. Data management is another essential aspect, requiring robust systems for data collection, storage, and analysis. Statistical analysis and medical writing ensure accurate interpretation of data and preparation of comprehensive clinical study reports.
Regulatory affairs play a crucial role throughout the trial. This includes managing interactions with national competent authorities and ethics committees, ensuring compliance with local regulations, and facilitating timely approvals. Project management is essential for coordinating all activities, ensuring adherence to timelines and budgets, and maintaining effective communication among all stakeholders.
Full-Service Clinical Trial Support
Full-Service Clinical Trial Support
The benefits of full-service support are numerous. Sponsors gain access to a team of experienced professionals with expertise in all aspects of clinical trial management. This reduces the burden on internal resources and allows sponsors to focus on their core competencies. It also enhances efficiency, as all activities are coordinated by a single provider, minimizing delays and errors.
Furthermore, full-service support ensures consistent quality and compliance. By adhering to standardized procedures and best practices, sponsors can mitigate risks and ensure the integrity of their clinical trial data. This is particularly important in the EU, where regulatory scrutiny is high.
In essence, full-service clinical trial support within the EU provides a comprehensive and integrated solution for sponsors seeking to conduct clinical trials. It streamlines the process, enhances efficiency, and ensures compliance, ultimately contributing to the successful development of innovative therapies and medical devices.
Full-service clinical trial support in Poland
Full-service clinical trial support in Poland, within the EU framework, ensures comprehensive management from protocol design to final reporting. This approach guarantees compliance with the Clinical Trials Regulation (CTR) and adherence to Good Clinical Practice (GCP) standards. Leveraging Poland’s experienced investigators and robust infrastructure, it offers efficient patient recruitment and data management.
Effective support includes navigating the Clinical Trials Information System (CTIS), managing regulatory submissions, and ensuring data integrity under the General Data Protection Regulation (GDPR). Strong collaboration with local ethics committees and the Polish Medicines Agency is crucial.
Furthermore, full-service support facilitates multinational trials, utilizing Poland’s strategic location and skilled workforce. It encompasses site management, monitoring, and logistical coordination, ensuring seamless trial execution and contributing to high-quality clinical research within the European Union.
Clinpharm is a contract research organization (CRO) with its main operations in Central Eastern Europe. They focus on early phase clinical trials of investigational products and medical devices. Clinpharm supports Sponsors, including non-commercial Investigator-Initiated Trials, in all aspects of the clinical trial, from study design up to the clinical study report. They provide services in the clinical development field, having experience in main therapeutic areas spanning from oncology and hematology through cardiology, neurology, respiratory up to rare diseases. Clinpharm’s expertise covers full service delivery of the clinical project, but their main focus falls on early phase clinical trials, medical device studies, and investigator-initiated trials.