Keep Your Clinical Studies on Track with Compliance Architects

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Ensure Your Clinical Trials Meet FDA Expectations

Keep Your Clinical Studies on Track with Compliance Architects

Ensure your clinical trials are well-managed with expert compliance support and adherence to regulatory standards.

Clinical studies are the backbone of pharmaceutical, biopharmaceutical, and medical device innovation. Yet, even a single misstep in study control, compliance, or quality assurance can lead to invalidated data, corrupted findings, or the shutdown of a study altogether. FDA has been aggressively going after study sponsors and IRBs so you need to be prepared. Compliance Architects can help ensure your clinical research is well controlled to ensure every aspect of your study adheres to Good Clinical Practices (GCP) and regulatory expectations.

Identify and Address Clinical Trial Risks

What Can Go Wrong?

Clinical trials face numerous data quality, study governance, and compliance risks, including but certainly not limited to:

Invalid or Missing Informed Consent: Patients must fully understand the study, their rights, and any potential risks. Improperly documented consent can result in ethical violations and regulatory action.
IRB Oversight Gaps: Institutional Review Boards (IRBs) are critical for ensuring patient safety and ethical study conduct. Miscommunication or failure to follow IRB-approved protocols can jeopardize the entire trial.
Non-Adherence to Good Clinical Practices (GCP): Failing to meet GCP standards—set forth in frameworks like ICH E6 R2 and R3—can lead to data being rejected by the FDA and other regulatory bodies.
Study Sponsor Mismanagement: Sponsors have significant responsibilities, from protocol development to monitoring compliance. Gaps in oversight or inadequate training of clinical staff can undermine trial integrity.
Patient Safety Concerns: Where study controls are lax or poorly defined, patient safety and study outcomes can be placed at risk. Both the study sponsor and the healthcare organization responsible for administering the study can risk reputation and regulatory ire.
Data Quality / Data Integrity Issues: Errors in data collection, reporting, or analysis can compromise study outcomes and waste valuable resources. A regulatory submission for a regulated product is only as good as the data that supports it. Data integrity and quality are paramount in achieving positive regulatory reviews.

Achieve Compliance and Excellence in Clinical Trials

A Path to Clinical Study Success

A well-designed, well-controlled and well-executed clinical study includes:

Meticulous Adherence to GCP Standards: Conducting trials with rigor and consistency ensures that data is credible, reproducible, and acceptable to regulatory agencies.
Comprehensive Informed Consent Processes: Every participant understands and willingly agrees to the study under IRB-approved standards and procedures.
Effective IRB Collaboration: Clear communication and regular updates with the IRB helps to maintain ethical and rigorous safety standards throughout the trial.
Engaged and Knowledgeable Study Sponsors: Sponsors actively oversee trials, provide resources, monitor performance, and ensure compliance.
Alignment with ICH and FDA Guidelines: ICH frameworks such as E6 R2/R3 provide not only international standards, they are also part of FDA study expectations, ensuring global and US FDA compliance.
Robust, Well-Controlled Clinical Data: Studies that are well-controlled, with strong data lifecycle controls, robust governance, and regular audits and oversight produce data that can be relied upon by regulators. Although strong study design and control can’t change the underlying data – good or bad – without such strong data governance, good data can be questioned and even disallowed, resulting in huge financial losses and failure to commercialize your product.

Expert Support to Keep Your Studies on Track

How Compliance Architects Can Help

At Compliance Architects, we specialize in creating robust clinical study quality assurance and governance programs, to enable and support your clinical trials from start to finish. We also help you to ensure your clinical organization has the tools – and personnel – to properly structure, control, and execute modern, cutting-edge innovation studies. Here’s how we make a difference:

GCP Clinical Study Compliance and Quality Assurance: We develop and implement appropriate and tailored processes to ensure your trial adheres to GCP standards, safeguarding the integrity of your data and protecting patient safety.
Informed Consent Management: Our experts design and audit informed consent procedures, ensuring full transparency with participants while meeting IRB and regulatory requirements.
IRB Coordination: We streamline interactions with IRBs, facilitating clear communication and timely approvals to keep your study on track. We can assist with communications, governance, issue review and analysis, and corrective actions.
Sponsor Support: We provide comprehensive training and resources for study sponsors, ensuring they fulfill their obligations effectively. From protocol development to compliance monitoring, we’ve got you covered.
ICH E6 R2 and R3 Alignment: Our team ensures your trial aligns with the latest updates to the ICH E6 guidelines, meeting both international and FDA standards for clinical research.
Comprehensive Audit and Monitoring Services: We identify risks and gaps in your clinical study processes, providing actionable solutions to enhance compliance and quality assurance.

Advance Your Clinical Studies with Confidence

Don’t let a lack of experience or capability derail your clinical trials. Compliance Architects brings the expertise, tools, and processes needed to ensure your studies meet the highest standards of quality and integrity. From GCP compliance to informed consent and IRB management, we’re here to help you navigate the complexities of clinical research with confidence.

Inspection Readiness & Enforcement

FDA Quality Consulting

Quality Assurance & Engineering

FDA Regulatory Consulting

Clinical Study Consulting Services

Data Services, Business Intelligence, EQMS

Pharmaceuticals

Medical Devices and Diagnostics

Biopharmaceuticals

Combination Products

Dietary Supplements

Cell & Gene Therapies

Cosmetics

Cannabis / CBD

Keep Your Clinical Studies on Track with Compliance Architects

Request a FREE 30 min Consultation

Ensure Your Clinical Trials Meet FDA Expectations