Real-world evidence recruitment
Real-world evidence recruitment for FDA drug approval support
Longitudinal patient studies need participants who stay engaged for months or years, not just a single session. This is where Primana Insights is built to differentiate.
What RWE and RWD actually mean
Two terms, defined the way FDA defines them
Per the FDA's own framing, real-world data (RWD) is health information collected outside a traditional clinical trial — electronic health records, medical claims, registries, and data from digital health technologies. Real-world evidence (RWE) is the clinical insight drawn from analyzing that data. RWD is the raw input; RWE is the analytical output.
FDA notes that RWE has long supported postmarket safety monitoring, and following the 21st Century Cures Act, the agency built a framework for using RWE to help support new indications for already-approved drugs and to satisfy post-approval study commitments — which is why longitudinal, well-documented recruitment matters so much for this kind of work.
Longitudinal study design
Recruiting once is easy. Retaining a cohort for a year isn't.
RWE studies that support regulatory submissions typically run over months or years, following the same patients and caregivers across multiple touchpoints. Our recruitment plans are built for that timeline from the first conversation — not adapted after the fact when dropout becomes a problem.
Realistic screening
We screen for participants who are likely to remain reachable and willing across the full study duration, not just at enrollment.
Ongoing contact cadence
A defined touchpoint schedule keeps participants engaged between data-collection moments, reducing the silent dropout that erodes longitudinal datasets.
Caregiver-inclusive retention
Where a patient relies on a caregiver, we build the caregiver into the retention plan directly, since caregiver availability is often the real constraint on participation.
Documented continuity
Consent, contact preferences, and any changes in a participant's status are tracked consistently so the study has a clean, auditable participation record.
Compliance touchpoints
Process awareness, not certification claims
We design our RWE recruitment processes with the following principles in mind. This reflects how we approach compliance — it is not a statement of formal certification or membership.
Informed consent
Participants are given a clear, plain-language explanation of a longitudinal study's purpose and duration before agreeing to take part, and consent is revisited if the study design changes.
Adverse-event reporting readiness
Fieldwork teams are prepared to recognize and route any adverse event or product complaint raised during a study promptly to the client, in line with standard pharmacovigilance practice for market research.
Data protection across US & UK
UK projects are designed around UK GDPR and the Data Protection Act 2018. For US projects, we design our handling of participant information with HIPAA's treatment of research data in mind — HHS guidance notes that a researcher working directly with participants under informed consent is generally not acting as a covered entity's business associate.
Regulatory context, not regulatory role
Primana Insights supports the research and recruitment side of RWE work. We are not a regulator and do not make determinations about what evidence FDA will accept — that judgment sits with the client and their regulatory advisors.
Planning an RWE study?
Let's talk through your longitudinal recruitment plan.
Tell us the population, the duration, and the markets involved, and we'll assess feasibility together.
Talk to Our Team