WELCOME TO CLINPHARM
Thank you for visiting our website and learning more about Clinpharm. We hope you enjoy your stay.
If you’re a small to midsize sponsor, or just starting with your development program, you may wish to have the full attention of your CRO in a partnership model.
We encourage you to contact with us so we can discuss how we run projects at Clinpharm to see if it fits your expectations.
ABOUT US
Clinpharm is a contract research organization (CRO) having its main operations in Central Eastern Europe. We focus on early phase clinical trials of investigational products and medical devices.
We support Sponsors including non-commercial Investigator-Initiated Trials in all aspects of the clinical trial from study design up to clinical study report.
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.
EARLY PHASE CLINICAL DEVELOPMENT
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 STUDIES
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.
INVESTIGATOR-INITIATED TRIALS
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.
OUR SERVICES
We provide various services to support the conduct of clinical trials and research studies. ClinPharm works with a range of clients, including pharmaceutical and biotechnology companies, medical device manufacturers, academic and government research institutions,
and non-profit organizations.
SITE
MONITORING
Site monitoring involves the ongoing review and evaluation of study sites and their activities to ensure that the trial is being conducted in accordance with the study protocol, regulatory requirements, and good clinical practice (GCP) guidelines. The goal of site monitoring is to ensure the integrity and accuracy of the data collected during the trial.
We assist with identifying and selecting appropriate study sites, managing relationships with clinical investigators, and overseeing the conduct of the study at each site. We perform all types of regular monitoring visit from site selection up to close-out, but we also offer remote monitoring, inspection readiness and oversight visits.
PROJECT
MANAGEMENT
Project management is a critical component of running a successful clinical trial. Clinical trials are complex, highly regulated, and involve many stakeholders, including study sponsors, investigators, clinical research organizations (CROs), regulatory agencies, and patients.
The project manager is responsible for planning and design, budgeting and resource allocation, risk management, timeline management, communication and collaboration, regulatory compliance, and data management. Effective project management ensures that the trial is conducted efficiently, ethically, and within regulatory guidelines.
REGULATORY
SERVICES
Regulatory services providers help sponsors and investigators develop a regulatory strategy, prepare and submit regulatory documents and ethics committee submissions, ensure regulatory compliance, assist with inspections and audits, and provide post-approval services.
By ensuring that trials are conducted in compliance with regulatory requirements, regulatory services providers help ensure the safety and efficacy of new treatments for patients We submit study protocols to regulatory agencies, manage approvals and report requirements ensuring compliance with applicable regulations and guidelines. Our expertise includes successful submissions according to the new processes of MDR and EU CTR.
QUALITY ASSURANCE & COMPLIANCE
Quality assurance in clinical trials refers to the processes and procedures put in place to ensure that the study is conducted in a consistent and reliable manner. It involves monitoring every step of the clinical trial process, from study design and protocol development to data collection, analysis, and reporting, to ensure that the trial meets the highest standards of scientific rigor, ethics, and regulatory compliance.
Quality assurance activities may include auditing, monitoring, and site visits to ensure that the study is being conducted according to protocol and that the data generated is accurate, reliable, and valid. The goal of quality assurance in clinical trials is to ensure that the results of the study are credible, reproducible, and can be used to inform clinical practice and public health policy.
STUDY DESIGN
& PROTOCOL
DEVELOPMENT
Study design and protocol development are essential components of clinical trials. The study protocol outlines the objectives, methodology, and procedures for conducting a clinical trial, while the study design is the overall plan for how the trial will be conducted.
The protocol should address key components such as the study population, intervention, study endpoints, randomization and blinding, data collection and management, ethical considerations, and statistical analysis. By carefully designing the study and developing a robust protocol, clinical trials can generate reliable and useful data to inform future clinical practice.
MEDICAL
MONITORING
Medical monitoring involves the ongoing review and evaluation of clinical data generated during a trial. The goal of medical monitoring is to ensure the safety of study participants and to evaluate the efficacy of the intervention being studied. Medical monitoring is overseen by a medical monitor or medical monitor team with expertise in the therapeutic area being studied.
Medical monitors evaluate safety and efficacy data, provide guidance on medical issues related to the study, and are responsible for reporting safety data to regulatory authorities and the study sponsor in a timely manner.
CLINPHARM SOLUTIONS
covering critical processes in the clinical trial.
PATIENT REIMBURSEMENT
STAY IN TOUCH
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REQUEST PROPOSAL
We welcome the opportunity to discuss your needs, opportunities, and challenges. Please contact us to schedule an initial conversation or to submit a request for proposal.