2Richards utilizes a systematic approach to inspection readiness to help you prepare for your next pre-approval GCP inspection. Some of the typical services we provide include:

Study Gap Assessments

• Pre-reading study documents to develop informed, targeted compliance questions

• Conducting open-book, structured interviews

• Exposing staff to an inspection-like environment and providing immediate feedback to improve responses

Inspection Strategies Development

• Supporting the study team in presenting the positives

• Developing tactics to minimize risk associated with inspection vulnerabilities

• Assisting with drafting of storyboards to simplify complex issues

• Developing data flow maps and other tools to “drive” inspectional questions

Inspection Logistics

• Developing workflows to ensure rapid, accurate fulfillment of inspection document requests

Mock GCP Inspections

• Pre-reading documents to ensure questions are informed

• Conducting interviews based on areas of anticipated inspectional focus using EMA and/or FDA inspection approaches

• Providing a concise written report with recommendations for remediation of any substantive findings

Issue Remediation

• Helping study teams remediate compliance issues

GCP Inspection Support

• Providing strategic support to the inspection team

• Developing responses to minimize impact of potential inspection findings

Do you have GCP inspection angst? Contact us today!

We can provide a risk-based assessment of your existing quality management system (QMS) and help you to identify areas for improvement. A few of these services include:

Risk Management Tools

• Developing customized, objective tools to evaluate risk to subject safety, data integrity, and regulatory strategy

• Advising on best practices for mitigating risk

For-cause (Directed) Audits

• Providing a risk assessment from information supplied by the sponsor

• Building a focused audit strategy

• Conducting adaptable audits

• Providing pragmatic feedback to management with suggested mitigation to areas of concern

Are you looking for assistance or advice with your GCP risk management? Contact us today to schedule a consultation.

2Richards applies in-depth knowledge and understanding of the clinical development process to help sponsors implement an effective quality management system that is the right fit for the organization. Some of these implementation/optimization services include:

Understanding the need

• Reviewing documentation and interviewing personnel to understand the business model

• Reviewing existing processes and procedures

• Identifying areas of compliance and/or business risk

Optimizing the process

• Assisting with development and implementation of an appropriate quality management system (QMS)

• Collaborating with your team to develop process flows and SOPs that actually work, an fit with your needs

Do you want to discuss how we can help implement or optimize your GCP quality management system?

Contact us today!

We offer a management service to provide various levels of GCP support to fit your needs. Examples of this include:

Interim QA management

• We can step in to fill the gap as your temporary head of GCP quality

Development, implementation, and management of audit programs

• We have extensive experience in developing, implementing and managing risk-based GCP audit programs.

Routine GCP support for study teams

• We can provide the GCP Advisor role to your study teams for ongoing management of operational issues as they arise during the course of study conduct.

If you’re looking for additional quality assurance support contact us today to schedule a discussion.

Organizations of varying sizes engage external GCP Quality Assurance resources to support them for a variety of reasons, such as:

• The need to fill a temporary senior staffing gap;

• To secure access to individuals with specialist expertise;

• To consult on an unusual or unique compliance matter.

2Richards have provided this support to many clients and would be delighted to help you and your organization as well.

We have extensive international industry experience of clinical quality assurance, covering decades of strategic and operational activities. We have advised on complex and sensitive compliance and ethical issues, and positively impacted business decision-making. 2Richards have sensitively conducted gap assessments of clinical study activities and on quality management systems and advised senior leadership on difficult issues.

We strive to evaluate compliance issues without preconceived ideas and to provide a candid assessment of any impacts to your study, program, or organization together with recommendations for risk remediation. We are recognized for delivering timely, pragmatic advice that helps inform senior management in their decision-making.

If you’re looking for additional GCP support contact us today to schedule a discussion.