Bringing expertise and excellence to your Phase IIIb/IV clinical study.
ethica CRO has a broad offering of complementary services to achieve your Phase IIIb/IV research objectives. Whether your study is voluntary or required by a regulatory agency, our study management team will help you:
Maintain regulatory compliance throughout your study’s lifecycle
Ensure the efficacy and safety of your therapeutic product
Constantly safeguard the rights and welfare of your research participants
Our team has the necessary experience to deliver post-market and observational studies across all major therapeutic areas, from small, local-based trials to large, complex, multi-national trials. Our biotech CRO also provides customized support for Investigator-Initiated Trials (IITs). We can liaise with the investigator, independently from the sponsor or granting agency, to ensure that a properly-constructed study protocol is developed, and that all necessary clinical trial logistics are put in place.
At ethica CRO, we recognize that the development of Phase IIIb/IV studies requires a different, further specialized approach compared to Phase III research. Whether the goal of your study is to support label extensions or to generate comparative data versus other marketed medications, ethica CRO has the tools and expertise to successfully design and manage your research program.
Our approach to the design of Phase IIIb/IV clinical studies is:
We will explore with you all available design and management options
We will help you avoid study over-engineering.
We will ensure that you meet your clinical objectives within budget.
At ethica CRO, it is our priority to ensure that our CRO services are delivered according to the highest standards of ethical and clinical practices and that the rights and welfare of human participants are constantly safeguarded throughout all phases of clinical research.
Beyond the clinical trial project management and biostatistics and biometrics services we offer, our expert clinical management staff can also create and manage either single-site or multi-centre, retrospective/prospective chart reviews, participant satisfaction surveys, and patient-reported outcome (PRO) validation, as needed. Additionally, our clinical management team has extensive experience with all types of peri-approval and post-marketing studies, including:
We understand the levels of data cleaning and analysis required for Phase IIIb/IV studies and we will never incur unnecessary costs by over-engineering study logistics. Importantly, our staff will always ensure that investigators are paid for the generation of worthwhile data and not for the number of participants enrolled.
ethica CRO’s investigator-initiated trials (IITs) management services are supported by highly-trained individuals with expertise to ensure proper study conduct, respect of timelines and deliverables, appropriate data management processes and statistical reporting. Importantly, this support is delivered without jeopardizing investigator independence or regulatory compliance (e.g. Office of the Inspector General (OIG).
Once your study is launched, ethica CRO will provide appropriate supervision and monitoring to ensure that study conduct is consistent with our accredited post-marketing research standard operating procedures (SOPs). This is to assure that all ethical rules are appropriately followed, and that regulatory and IRB compliance is achieved and constantly maintained throughout your study’s lifecycle.
