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Real world solutions that matter

About CERobs Consulting

CERobs Consulting provides individualized consulting services for study design, methods and improvement of patient-centered outcomes research, comparative effectiveness research, pragmatic randomized trials and real world evidence (RWE) observational research. Consulting services range from conceptualization of research questions and endpoints to protocol development and manuscript preparation.

RWE refers to data gathered from actual patient experiences in real-life settings, outside of traditional clinical trials. This evidence is used to assess the effectiveness and safety of drugs, devices, and other interventions in everyday healthcare.

RWE auditing involves reviewing and validating the quality, accuracy, and regulatory compliance of real-world evidence data, ensuring that studies and their results meet necessary standards for clinical and regulatory purposes.

COAs measure a patient’s health outcomes based on their own reports (patient-reported outcomes), or clinician/observer assessments. These tools help gauge the impact of a treatment from the patient’s perspective and are key in supporting regulatory decisions.

EVIDENCE SYNTHESIS

Evidence synthesis combines data from various studies, including systematic reviews and meta-analyses, to form comprehensive conclusions about a treatment’s safety and effectiveness. This helps inform decisions for healthcare and regulatory bodies.

REGULATORY STRATEGY

Regulatory strategy involves developing a clear plan to meet the necessary requirements for obtaining approval from regulatory bodies (like the FDA) for drugs, devices, or treatments. It ensures compliance with regulations throughout the product's development lifecycle.

CERobs Consulting Real-World Evidence Expert Leaders, Dr. Cynthia Girman and Dr. Mary Beth Ritchey

As two leaders in the field of pharmacoepidemiology and outcomes research, Dr. Cynthia Girman and Dr. Mary Beth Ritchey saw an opportunity in their shared interests and synergy in their skills and expertise that led them to form a unique partnership.

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“The CERobs team onboarded quickly and worked with us to develop an innovative, yet appropriately complex solution. They engage holistically and tackle each project with efficiency and skillfulness. They are trusted advisors who are embedded in our culture and our company. Their expertise continues to be invaluable as we plan for our next stage of growth.”

- CEO, Pharmaceutical Company

click to see what others are saying about us

"CERobs is top shelf boutique vendor and partner. Their deep methodological skills coupled with practical experience, and very current understanding of the RWE ecosystem is a rare find.

 They have been a great resource and partner from strategy development to execution."

- Senior Director, RWE, Large Pharmaceutical Company

"I thoroughly enjoyed working with CERobs!  They are truly leaders in the field and their reputation is well-deserved. They provided innovative insights, often under tight time constraints, always exceeding expectations. Their professionalism was matched with a fun and collaborative spirit, making the project execution feel enjoyable and rewarding."

- Senior Director, RWD Strategy and Implementation

Teal Orb, CERobs Consulting Visual

"CERobs worked closely with us to develop and conduct clinical outcome assessments to support our primary endpoint for our Phase 3 registration trial. Their recommendations and deliverables were always well-informed, evidence-based and very well-written for our regulatory purposes."

- Chief Development Officer at a Pharmaceutical Company

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