Strategic Clinical Study Execution (E) Model
We have built a solid foundation with experienced professionals and offer a depth of services to help you with your drug development challenges and manage complexities with conducting global clinical studies.
We will drive your clinical studies as boots on the ground as well as integrate with your internal functional team as an extension of their team while driving the execution of your clinical studies at a country and site level.
The PAR Clinical team is an experienced and passionate group of professionals with our primary focus is on efficiently managing your project life cycle, reduce inefficiencies and redundancies to meet strategic goals. With greater adaptability and flexibility, we will drive an efficient execution of projects while biotech companies can focus on the strategic aspects of your clinical development.
Through our collaborations, we are positioned to drive your clinical studies globally.
Clinical Project Management
- Proactive Trial Management
- Proactive and Effective Communication
- Early Risk Identification and Proactive Mitigation
- Establish a Governance Structure and Focus on Key Performance Indicators
Clinical Site Identification, Feasibility and Study Start-Up
- Faster Site Identification using our partner tool "Site Insight".
- This tool is built on AI/ML predictive modeling to help identify sites in a precise location globally.
- Get predictions of sites for every therapeutic area.
- Access feasibility evaluation of the site for specific study
- Begin study at sites with high patient enrolment
- Proactive, Experienced, Agile, and Nimble Feasibility and Site Start-up team.
Site Management and Monitoring
Our clinical trial associate and In-House CRA models help us provide our sites and clients with adequate site management support and oversight.
Our skilled and well-trained clinical research associates (CRAs) ensure the highest quality review of data and effective interaction with study sites.
Our clinical research associates conduct on-site monitoring visits throughout the study to:
- Oversee data collection
- Review source documentation and case report forms
- Ensure regulatory compliance
- Resolve data queries
- Conduct interim analyses as requested by clients
Data Management and Biometrics (Bio-Stats and Statistical Programming)
Our clinical data management team has significant experience working across multiple EDC systems. Our internally built EDC platform through our collaborations is a feature-rich and powerful data capture solution. The core features are Speed, Usability, Flexibility, Ease and Configurable.
Our Biostats team has capabilities to support our client needs from clinical trial design, sample size calculations, randomization schedule, adaptive trial designs, SAP development, Mock Shells, ADaM specs, interim analysis to CSR support, Publication support and Meta Analysis.
Our Statistical Programming team is experienced and can support our client needs from SAS & R Programming, SDTM-Spec, Statistical Analysis Programming, Production and Validation Macro programming, ISS/ISE report creation, etc..
Medical Monitoring, Clinical Science and Medical Writing
With an experienced team on board, we offer 24hrs Medical Monitoring and surveillance, Medical data review, Ongoing Safety Surveillance, Safety Review Committee management etc.
Clinical Supply Chain Management
Planning and managing clinical trials is an increasingly complex task. Unlike standard supply chains, there are many unpredictable factors.
Our best-in-class clinical trial supply chain management experts are supported by our customised technology. This means we are uniquely positioned and equipped to offer the most comprehensive, end-to-end, clinical supply chain management service in the industry.
TMF Management and Digitization
Our experienced team is structured to manage you eTMF and ensure that they are always inspection ready.
We also offer services to digitize your legacy clinical study paper TMF documents which can be filled appropriately in a eTMF or could be maintained on Cloud for future reference.