Customized Compliance and Training Services Designed to Fit Your Study

Helping You Create a Healthier World Through Expert Compliance Guidance

A Recognized Leader in Compliance

Receiving the highest quality data to support your submission to regulatory authorities is vital to the success of your clinical trial. Our experienced team of quality and compliance experts use a hands-on approach and proven processes to support our internal teams and sponsors.

Our compliance team is comprised of four functions to serve your clinical trial: quality management systems, vendor management, training and data protection-GDPR consultancy. These departments work in close cooperation with each other. The auditing arm of compliance, quality assurance, runs independently from the operational departments. Together, they seamlessly maximize efficiencies through a streamlined, adaptable process that keeps our studies and teams on track.

Quality Assurance Services

Auditing You Can Count On

Our global team of experienced quality officers, auditors and managers assure ongoing, long-term compliance and audit readiness for your clinical trial. We can provide contract quality assurance and auditing services on your behalf. We offer the following suite of services:

Risk-based assessments and audits of systems (including sites and training), vendors and offices
Coordination of external audits and follow up to closure
Facilitation of operational excellence and continuous improvement within standards
Management of investigations using a risk-guided approach
Assurance of vendor compliance and networks
A competency and role-based learning system to design, provide and measure effective training

Want to learn more about what our quality assurance and audit services can do for your clinical trial? Contact our team today!

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Keep Your Study Safe With GDPR and Clinical Trial Data Protection

The protection of personal data is a critical aspect of any clinical trial. We have a comprehensive, global privacy program designed to respect and protect your patients’ personal data.

Our internal privacy program is designed to incorporate data protection in all our processes and procedures with the goal of achieving Privacy by Design for your study. This includes making sure our SOPs, internal documents and contracts are fully compliant with relevant data protection laws. We also incorporate security measures for all internal systems, staff training and other measures to secure core data protection compliance.

Apart from this internal privacy program, our data protection team will guide you through EU and non-EU GDPR controller responsibilities. This includes assistance with EU 2016/679 General Data Protection Regulation (GDPR) requirements.

By combining our superior expertise and experience in clinical research and data protection, you receive practical, vetted solutions for your study.

GDPR - Data Protection Services

Quality Management Systems for Improved Insight

To safeguard your clinical trial, we provide a company-wide quality system that effectively manages risk and ensures you are always inspection ready. It uses global quality and escalation policies specifically designed to ensure the highest consistency each and every time.

Our services include:

Case management service
Controlled standards management
Key performance indicator development and monitoring
Risk management
Vendor management

By offering the most extensive, dependable quality management systems available, we ensure you receive the insight and oversight you need for your clinical trial.

Compliance Sponsor Testimonial

“Your deliverables are at a gold standard compared to other vendors. Overall, The QMS that is implemented is well defined and well structured, allowing for flexibility in execution. It’s like you’ve done this 1000x before.”

Biotech - Director Quality Assurance

Added Service and Value Through Vendor Partner Management

Vendor partnerships provide access to services that are key to the success of your clinical trial. When it comes to supporting your study, we have created a comprehensive ecosystem of best-in-class partners for each center of excellence therapeutic area in order to bring efficiencies and benefits that add value to your study programs.

In addition to providing the most qualified network of partners, our Culture of Accountability [Link to Why Pham-Olam page] means that we take responsibility for their performance. One way we do this is by deploying a comprehensive set of tools that help to manage these partnerships and services effectively, remove potential risk and track performance. These tools include:

A vetted vendor database that allows us to facilitate any service needed
The innovative bowtie method [Link to Why Pharm-Olam page] which allows us to proactively remove potential risk
Measured performance through established key performance indicators (KPIs)
A prequalification tool like vendor risk assessment cards and business evaluation cards tailored to specific vendor types
Cost-effective preferred pricing which is passed on to sponsors

To effectively manage vendor partner performance, we review KPIs regularly and provide the support and oversight needed to ensure they are met. All of these factors work together in your favor to streamline execution and maximize success at all levels.

Complete Training Services to Prepare Your Site Personnel

Making sure study personnel are fully prepared to perform every task associated with your clinical trial is the central purpose of the training services team. We have numerous filters in place to ensure that training is not only aligned for clearly pre-identified business needs, but that the staff delivering the training is supported and ready to deliver across multiple modalities to create the optimal learning experience.

By employing a five-step training analysis strategy, we make sure that all training has predefined requirements to ensure the most effective use of nonoperational time. Integrating with our quality management system ensures a continuous process of needs identification and support implementation across all departments via KPIs and audit trending direct from source.

What’s more, we are part of the TransCelerate Mutual Recognition (MR) Program for ICH E6 Good Clinical Practice (GCP) Training targeted at investigator site personnel. This helps to ensure that teams understand their accountability within your clinical trial environment which is especially beneficial to bring research-naïve sites up to speed. Our online training catalogue exceeds the minimum criteria identified as necessary to enable the mutual recognition of GCP training. To satisfy these minimum criteria, the training includes a GCP overview, the principles of ICH GCP and investigator responsibilities all within a concise, mobile-ready platform that is accessible 24/7.

By taking a comprehensive approach to training that includes access to a program of fully comprehensive data and a mobile-ready platform, our team is equipped to prepare your clinical trial personnel to meet the ongoing needs of your study.

Digital Compliance Conference