Through our global and local know-how, PVR designs projects that fully meet complex and diverse local regulatory requirements. Fully adhering to local legislation ensures that data collected by our team shall be fit-for-purpose and accepted by the EU, US and other regulatory bodies.
Regulatory document preparation and collection
Agency submission
interactions (RA&ECs)
Medical writing is a key element in the success of clinical trials. PVR’s experienced team of medical writers shall tailor-make all necessary document to fit your clinical trial and in compliance with all legal and regulatory requirements. Medical writing is not a siloed activity. Top quality documents are achieved through cross functional integration with other PVR divisions such as regulatory affairs, clinical operations and quality. Our medical writing service includes clinical study reports, ICFs, SOPs, protocols, submissions, posters, presentations, investigator brochures, patient materials and scientific publications.
Informed consent form (ICF)
Investigator's brochure (IB)
Expert oversight and management is a key factor in the success of your trial.Our project managers coordinate and harmonize all aspects of the clinical trials, leading cross-functional cooperation between finance, biostatistics, clinical monitoring, medical writing and data management, as well as external vendors. PVR designs a detailed strategy for each study, which includes a transparent and well-managed budget. We always aim to exceed your expectations!
Study start up management
Investigator sites management
Project quality management
Project closure and Archiving
Our team of CRAs handle all activities including sire feasibility, site selection and activation, site training, contract and budget negotiations, remote and onsite monitoring, oversight of data collection, case report form review, tracking protocol deviations, tracking patient status and ensuring adherence to regulatory requirements. Our team of CRAs is highly trained and ensure accurate and consistent data collection, as well as effective trial execution.
Site identification & feasibility
Monitoring and compliance
Subject enrollment / retention
Study specific training to site personnel
Essential documents collection, review and processing
PVR can manage all aspects of your clinical trial from start to finish or tailor our services to your specific needs.Our highly professional clinical monitoring teams are strategically located to ensure (they have) knowledge of the local language and culture. We ensure clinical trials are conducted with full regulatory compliance from start to finish.Our Clinical Monitoring Services include remote and on-site visits:
Pre - study visits (Site selection / qualification visits)
Routine monitoring visits
Investigational product and materials accountability
PVR has a diverse team of biostatisticians, including some of the most experience in the industry. Our team shall work with you from planning to submission. The biostatistics services include statistical consulting, study design, data integration strategy and implementation, communication with health authorities, review of authority feedback, data surveillance, risk assessment, statistical assessment, reporting of results, data integration and standardization. Our biostatistical capabilities will support adaptive and innovative trial designs.
Identification of the right statistical tests
Identification of the optimal clinical trial participants number
Assessment of the data-to-hypothesis compliance
PVR keeps its focus on what happens with the patient during the clinical trial and maximizes its efforts on patient engagement and retention before, during, and after the patient visits. We understand how important it is to keep patients engaged and loyal to a site for the success of any long-term project.
The rigorous collection of drug safety data is essential for the success of clinical trials. Pharmacovigilance is required well beyond market authorization. We detect and minimize safety risks and concerns. Patient safety always comes first
Safety and efficacy reports
Handling of AE, AESI, SAE
What is R&D in clinical trials?
R&D in clinical trials is a comprehensive and structured process, pivotal to the pharmaceutical industry, aimed at discovering, developing, and delivering new medical drugs, devices, or therapies to the market. The process involves several stages, each critical to ensuring the safety, efficacy, and cost-effectiveness of new treatments.
1. Discovery of therapeutic approach
This initial stage involves identifying new drugs through various methods, such as understanding disease processes, testing molecular compounds, or recognizing unanticipated effects of existing treatments. The discovery phase filters out numerous compounds to find those promising enough for further development.
2. Preclinical testing
Prior to human trials, new drugs undergo rigorous preclinical testing, often using in-vivo animal studies. This stage is crucial to establish the safety and biological activity of the drug.
3. Clinical development
This phase involves clinical trials in humans, during which the drug's interaction with the human body is thoroughly studied. The trials are designed to address different phases, each with specific goals, to gather detailed and voluminous data required for regulatory approval.
4. FDA review and approval
Drug developers file an application for marketing the drug after clinical trials. The approval is contingent upon the evidence provided from preclinical and clinical research demonstrating the drug's safety and efficacy.
5. Post-market monitoring
After a drug is approved and enters the market, its safety profile continues to evolve. This phase involves monitoring the drug's performance in the general population and addressing any emerging issues or side effects not observed during the initial trials.
