A full service CRO, running more efficient clinical trials

Services

One of the specialties that we’re often complimented on is our people. Our highly qualified people come from diverse CRO and Pharma backgrounds, bringing unbeatable expertise and broad capabilities that are fundamental to the success of your trial.

Services Overview
Services overview

We understand that successful clinical trials need more than expert capabilities. You need a partnership you can trust, that provides all the resources you need in one seamless process. Here at PCG, we all share great passion for excellence in clinical research. We believe in clear communication, hard work and always looking forward. As you’ll discover, our PMs won’t hesitate to go the extra mile to provide you with everything you need to reach your destination in time. Whether you need assistance with parts of your trial or require our full services, we’ll provide a fully customised package to suit your needs. Read more about our core services below.

Advisory

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

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

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

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

Read more on our Biometrics page.

Biometrics

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
Medical Writing

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

Read more on our EDC technology page.

RBM

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

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

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

Read more about our medical device page.

Global reach

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
Strategic business support

Strategic business support

A business-driven approach to drug development is essential to ensure your product meets market needs, while also differentiating it from current standards of care.

Through our market assessment and Target Product Profile (TPP) services, we identify the information you need to define your product opportunity and potential value for investors. The findings will shape the most effective design for your clinical programme, which can be optimised with our Advisory board, to increase your chances of a successful study.

• Market analysis, including consultation with key opinion leaders

• Identification of unmet needs and opportunities

• Development of your Target Product Profile (TPP)

• Sales forecasting

• Need-driven clinical study design

• Portfolio review, business planning and product marketing strategy

Contact us to set up a meeting with our partner Sven Undeland, our expert in TPP and Market assessment to explore a strong business strategy for your product. ​

To read more about our company, download our brochure.

You can trust us to manage your complete biometrics package, improving your trial efficiency while minimising the risks of working with multiple CROs. Whether you're looking for a full service provider or specific project support, we'd like to hear from you. Contact us to discuss your bespoke biometrics requirements.

Send us an email
Biometrics
Biometrics

Our company was built on biometrics expertise and it has remained central to our flexible approach as we’ve expanded our service offering. We believe that well-planned studies with intelligent data management go a long way towards ensuring the success of your clinical trials.

Excellence in Biometrics

Excellence in Biometrics

Our comprehensive services cover the full biometrics life cycle, from initial study design and protocol development to statistical analysis and clinical study reporting. We take complete responsibility for managing your biometrics needs, including input and continuous support into your risk-based monitoring (RBM) plan, eCRF design, data validation, statistical analysis and medical writing. As master users of Viedoc™, the cutting-edge electronic data capture (EDC) system, we’ll provide effortless eCRF set-up and create highly sophisticated functions optimised for your study. In addition, we provide biostatistical and medical writing input to Data and Safety Monitoring Boards (DSMBs).

Biometrics Overview

Biometrics Overview

Our advisory team is always on hand to provide guidance for optimisation of your study design, in order to meet your objectives and ensure delivery of high quality data.

Our biometrics services include:

  • Study design – enhanced by our strategic advisory team

  • Protocol writing – supported by our cross-disciplinary and broadly experienced medical writing team

  • eCRF set-up – development of an advanced but user friendly eCRF with smart built-in edit checks for real time data cleaning

  • Project management – executed by a dedicated project manager and Viedoc master-user who takes responsibility for all biometrics activities, from start to finish

  • Data management – data validation through advanced centralised monitoring including SAS-programmed checks as well as standard and customised reports, medical coding and clean file/database lock procedures

  • DSMB support – DSMB management and provision of study data for efficient data evaluation

  • CDISC standards – study data packaged into CDISC-compliant standards (SDTM/ADaM) and/or sponsor-specific standards

  • Biostatistics – knowledgeable and customer-focused support for randomisation, statistical analyses and statistical reporting, ensuring correct data interpretation and clear conclusions

  • Medical writing – proficient writing and quality control of clinical study reports, safety summaries and publications

PCG - The Way Ahead.

More to discover
Our Services
Testimonials

You can trust us to manage your complete biometrics package, improving your trial efficiency while minimising the risks of working with multiple CROs. Whether you're looking for a full service provider or specific project support, we'd like to hear from you. Contact us to discuss your bespoke biometrics requirements.

Send us an email
EDC Technology

As master users of Viedoc™, a cutting-edge, world-class electronic data capture (EDC) tool, we’ll provide effortless electronic case report form (eCRF) set-up and give you complete control of your study from the beginning

Cutting-edge EDC technology

Cutting-edge EDC technology

The next-generation Viedoc technology is core to our delivery of robust and compliant studies. This highly sophisticated electronic data capture system has a surprisingly simple user interface with immense flexibility. We can tailor make the system to meet your study objectives. We can also accommodate all of your data management, quality and safety monitoring requirements. Viedoc’s effective data capture and adaptive support capabilities provide easy reporting at any point during the process.

ViedocMe

Comprehensive trial data management

The Viedoc technology allows complete trial management, both on-site, across multiple locations as well as off-site. ViedocMe™, the ePRO function fully integrated with Viedoc, also allows study participants to self-report through their mobile devices, at any time.

Overview

Advanced eCRF design

  • Sophisticated functionality, optimised for your study

  • Enables CDASH-compliant and dynamic data collection

Simplified trial management

  • Includes built-in randomisation and medical coding functions

  • Study status provided in real time to enable complete access to your data

  • Comprehensive data handling and reporting, with simplified administration of users and sites

Robust data management

  • Advanced package of in-built and off-line edit checks, minimising data issues

  • Oversight of data management, query handling and data entry

With PCG’s expertise and technology, we’ll deliver compliant reporting and study data of the highest quality. We’ll also provide you with full Viedoc training and a dedicated project manager as a single point of contact throughout your trial.

Related links:
Biometrics package
Services
Testimonials

Read more about the revolutionary Viedoc technology.

You can trust us to manage your complete biometrics package, improving your trial efficiency while minimising the risks of working with multiple CROs. Whether you're looking for a full service provider or specific project support, we'd like to hear from you. Contact us to discuss your bespoke biometrics requirements.

Send us an email
Medical Device
Medical Device

Clinical investigations for medical device often require a different set of services and competencies compared to pharmaceutical studies. That’s why we have a dedicated and experienced medical device team to take care of your medical device studies. We perform clinical investigations for all medical device classes, both before and after CE-labelling.

Work with a dedicated team

Work with a dedicated team

Our Medical Device team offers broad experience in planning, conducting and reporting of medical device studies, including both pre- and post-market clinical investigations. You can rely on our committed team to deliver the knowledge and excellence that you need for an efficient study. You can also trust our team to work to our quality control system, which is based on ISO 14155 and the EU guidance for medical device clinical studies (MEDDEV).

Access excellence in medical device studies

Access excellence in medical device studies

Our comprehensive services include the following

  • Study design and clinical investigational plan development

  • Project management and site monitoring

  • Submission of requests for study authorisations to the competent or regulatory authorities

  • Submissions for ethical approvals

  • Safety reporting

  • Central monitoring

  • Biostatistics

  • Study reporting

  • Publications, abstracts and posters

As master users of the next-generation Viedoc™ technology, we will set up a sophisticated and flexible EDC system to support robust data collection for your medical device clinical investigation.

Learn more about Viedoc.

Contact us to find out more about our capabilities for your specific medical device study needs.

You can trust us to manage your complete biometrics package, improving your trial efficiency while minimising the risks of working with multiple CROs. Whether you're looking for a full service provider or specific project support, we'd like to hear from you. Contact us to discuss your bespoke biometrics requirements.

Send us an email