Let’s Create a Unique Problem Solving a Next-Generation Platform for All Critical Function Across the Value Chain
PVR’s biostatisticians work with clients to determine methods for collecting, analyzing and presenting data while maintaining compliance with regulatory guidelines. Our programmers create customized tables, optimized for unique study designs.
Our Statistical Services Includes:
- Statistical review of protocol and CRF
- Power and sample size calculations
- Randomization schedules
- Data Integration and Mining
- Statistical Analysis Plans (SAP) creation/review
- Statistical modeling/Exploratory analysis
- PK/PD Modelling
- Regulatory Consulting and Representation
- Interim Analyses
- Analysis, Reporting, and Publications
- ISS/ISE Planning, Analyses and e- submission
- Patient Profiles and ad-hoc reports
- Statistical Reports (CSR, Manuscripts, IB)
- Development of CDISC compliant outputs
- TLF creation, In-text table and appendix
PVR’s Statistical programmers have years of SAS® Programming expertise, allowing them to complete the programming task accurately and in a timely manner.
Some of the tasks carried out by the statistical programmers are:
- CDISC Conversion (Mapping to SDTM)
- Generation of Analysis Datasets (ADaM)
- Generation of Tables, Listings and Figures/Graphs
- Validation of Data
- Creation of CRT Packages (Reviewer’s guide; Define.xml, Patient Profile)
PVR provides a full range of data management services from Phase I through to post-marketing trials keeping up the upholding a standardized, process-driven approach. PVR has also developed proprietary tools and standards to work with these products to further enhance the process and provide our clients with a streamlined and efficient approach to data management that results in a quality end product. We focus on designing, building and deploying clinical trial databases faster more effective and efficient.
Our Clinical Data Management Services include:
- EDC and Paper Trial Set-Up & Management
- CDASH Compliant deliverables
- Data Management Plan (DMP) development
- CRF/eCRF design and development
- CRF Annotation & Review
- Database design, creation, and maintenance
- UAT Testing
- Data validation specifications
- Edit checks Programming & Testing
- Query Management
- Medical Coding
- SAE Reconciliation/ Lab Reconciliation
- Database lock activities
PVR Technologies offers drug safety and risk management services for pharmaceutical, biotechnological, medical device companies to ensure timely submission of quality adverse event data to various regulatory authorities across the globe. The PVR’s Pharmacovigilance teams have the knowledge of local regulations, standards of care and cultural customs needed to identify and assess risks during clinical trial safeguarding the subject’s safety.
Pharmacovigilance and Drug Safety Services Include:
- Case coding and Narrative writing
- Safety Database Services
- Individual Case Reporting
- Aggregate Safety Reports
- Periodic Safety Update Reports (PSUR),
- Benefit-risk evaluation report (PBRER)
- Periodic Adverse Drug Experience Report (PADER)
- Developmental Safety Update Report (DSUR)
- Investigational New Drug (IND) – Annual Report
- Safety/ Risk Management Plan
- Signal Detection and analysis
- Adverse event and Product Complaint Management
PVR offers proven solutions and exceptional quality, ensuring successful delivery of regulatory services from locations around the world. Our regulatory affairs experts help to go through the entire drug development and regulatory submission process to meet the regulatory goals.
PVR offers a wide range of Regulatory Services including:
- Regulatory consulting
- Clinical Development Plan
- Regulatory eCTD dossier preparation, publishing and submission
- Regulatory Submissions: IND, NDA, ANDA, BLA and CTA applications (Paper & eCTD
- Global submission management and report publishing
- Medical writing
- License maintenance for marketed products
- Technology assessment,
- Regulatory Labelling and Liaising
- Global Regulatory guidance and support
PVR offers a fully compliant and high-quality complete package of quality assurance services. From outsourcing of individual activities to the setup and management of an effective and efficient global quality system, PVR provides solutions specific to the requirements of our customer’s organization and products.
PVR quality team ensures planning, coordination, control, and continuous improvement of processes and methods are established to control the quality of studies.
Quality Assurance and Validation services include:
- Validation Planning & Design Assessment and Monitoring
- On-Site Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP) Training
- Quality Management Systems
- GCP/ICH compliant processes
- CAPA (Corrective and Preventive Actions)
- Quality Management Reviews and Quality Audits
- Quality System Regulations / ISO standards
- Review and Validation of Technical Documents
PVR Technologies Inc. is an equal opportunity company. We have based our HR philosophy on the values of trust, transparency and competency. By choosing the right people for the client’s projects we have ensured not only project success but also achieve complete client satisfaction.
The non-stress environment at our workplace puts work and play put in the right balance. This has helped us to sustain each team member’s interest in work, greater productive and far lesser attrition rates. We provide our personnel with a good and congenial work environment, transport and canteen facilities. Facilities for indoor games were arranged at the staff canteen.
The challenges associated with each client’s project have put our project readiness in question. To counter this challenge effectively we have taken measures to enhance the readiness of personnel for the present and future project challenges.
The in-house training and expert interactive sessions have been made part of the employee orientation and on-job training activities. At PVR, skill development by conduct of job enrichment programs is a continuous activity.
The routine at PVR includes outings, celebration of birthdays, and arrangement of get-together parties at regular intervals of time. It has been integral to our work culture that good working conditions and healthy social life is a big booster of employee’s productivity, and keeps them focused at work.
PVR Technologies, 501 Allendale RD Ste 201, King Of Prussia, PA 19406.
610 337 1935