PCG Clinical Services
 | |
| | |
| PCG Clinical Services | |
|---|---|
| Type | Private |
| Industry | Pharmaceuticals |
| Founded | 2003 |
| Headquarters | Uppsala,Sweden |
| Number of employees | 51-200 |
PCG Clinical Services – Not just another CRO. We’re a Swedish-based full-service contract research organization that provides clinical studies, medical writing, data management, biometrics and statistical services for pharmaceutical, biotech and medical device companies worldwide. We’ve been leading improvements in clinical studies since 2003, through our scientific expertise, progressive EDC technology and more effective ways of working. Our unique offering brings you the global reach, expertise and comprehensive services you might expect from a large company, combined with the agility, focus and cost-effectiveness of a small company. Our capabilities range from early study advice through Phase I to Phase IV trials, supported by our flexible global partner network. Our greatest asset is our highly competent team, driven by our CORE values of Commitment, Ownership, Responsibility and Excellence. These have a firm place at the heart of our company and influence everything we do, strengthening the lasting relationships that we value with all of our partners.
Contents
SERVICES
Advisory
Our Advisory board offers invaluable guidance for optimising your study design to meet your objectives and deliver high quality data.
Benefit from:
- Precision planning
- Smarter study design and study conduct
- Improved study efficiency
- More effective use of resources
- Expert compliance advice
Project Management
With studies and trials in over 21 countries, our PMs have a reputation for quick decision-making, flexibility and timely results.
We will do our very best to make sure your project:
- Starts in time
- Ends in time
- Is properly documented
- Passes any inspection
- Is one of many successful projects with us
Clinical
Our CRAs provide exceptional site management skills helping sites to deliver perfect results, from start to finish.
We also deliver outstanding services within:
- Feasibility
- Site selection
- Submissions
- Monitoring and risk-based monitoring
- Safety reporting
Biometrics
Specialising in statistics and data management, our biostatisticians and SAS programmers are well known for the exceptional quality of their work.
We’re also widely experienced in:
- Randomisation and sample size analysis
- Conversion of data into CDISC SDTM and ADaM format
- Preparation of statistical analysis plans
- Statistical analysis
- Preparation of tables, listings and graphs
Medical Writing
With over 30 years’ experience, we offer expertly written and regionally compliant documentation, ready for submission to authorities such as the FDA and EMA.
You can trust us with writing your:
- Abstract
- Study protocol and investigational plan
- Study report
- Scientific publications
- Patient narratives
Electronic data capture (EDC)
Electronic data capture (EDC)
We deliver tailor-made software solutions, powered by the most versatile data capture system in existence - Viedoc, developed by PCG.
We cover it all:
- eCRF design and set-up according to CDASH
- eCRF and edit check specifications
- Edit check programming and execution
- Data validation
- User administration
Risk-based monitoring
Our risk based monitoring strategy prevents or mitigates important and likely risks to trial data and process and enables us to focus our efforts on the most relevant data and key risk factors of your trial.
Our approach includes:
- On-site and centralised monitoring
- Focused source data verification in the eCRF
- Directed monitoring visits to the site that need most attention
- Regular review of trial data to identify potential errors early and ensure consistent data
Quality Assurance and Training
We work to the highest quality requirements across numerous GXP and ISO standards for Medicinal and Medical Device clinical trials, software development and CE marking of software as a medical device class I.
Our Quality Risk Management System (QMS) includes:
- Annual risk-based internal audit program
- Risk-based vendor assessment and management
- Incident/complaint management
- Validated computerised systems used in clinical trials
We also provide annual training in regulations and professional training in key skills.
Medical devices
Access specialist expertise through our dedicated Medical Device group, which plans, conducts and reports on medical device studies, according to ISO 14155 and MEDDEV.
Our comprehensive services include:
- Study design and protocol/CIP development
- Project management and clinical monitoring
- Data management and biostatistics
- Studies for products before and after CE-labelling
Global reach
We’ve built a network of trusted CRO partners worldwide to provide added flexibility and global coverage for your specific study requirements.
Our partners are:
- Fully verified and audited in accordance with our high standards and quality systems
- Committed to our high standards and CORE values
- Chosen to provide a fit-for-purpose extension to your project team
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