Retrospective Studies
Are You Looking for a CRO for Your Retrospective Study Who...
ARG is known for conducting successful retrospective studies in many therapeutic areas.
Tell Us About Your NeedsWhy Choose ARG for Your Retrospective Study?
Retrospective studies look back through time using existing records to examine safety, clinical, and (healthcare) utilization data.
A clear advantage of conducting retrospective studies is that they do not need to follow subjects into the future, which typically reduces timelines and cost.
Retrospective studies must be managed by an experienced CRO. If sponsors choose a CRO without a proven track record, they miss out on the benefits of shorter timelines and lower costs. Worse, they put their data at risk of poor analysis methods that yield unhelpful or unusable results.
ARG has conducted successful retrospective studies for years. From our experience, we’ve identified several critical success factors that we bring to every study.
ARG has found that successful retrospective study requires sponsors to be critical about the following:
Protocol for Data Collection. Comprehensive data collection strategy. Important to establish early in the process to alleviate challenges during the course of the study.
Robust Feasibility. Analysis to confirm that sites have the data necessary for study analysis in their medical records.
Ask sites to provide examples of data points routinely collected to help identify risks in data collection and interpretation:
- Where are the patient source documents located?
- How they will be provided to the CRO for monitoring.
- Is the data electronic?
- Can it be downloaded to the new database for review?
- Does someone need to manually enter it from paper?
- How is mismatched or missing data handled in the data analysis?
Identify Go-To Site Resource. Site-based resource who can efficiently navigate source documents in order to address questions and resolve queries from the CRA.
Your CRO should also be an asset when building a database. ARG’s Data Management team suggests building a database with the following flexible characteristics:
- Naming conventions
- Missing data labels (not done, unknown, NA)
- Drop down options vs. free text fields
- Appropriate edit checks to reduce the frequency of automatic queries
- Alignment with site EMR/EHR data.
ARG employs frequent data reviews to assess data gaps, data entry, and data presentation (i.e. dry run TLFs, patient profile summaries).
Our unique mix of technical and medical experience enables us to help sponsors conduct successful retrospective studies.
- Chart review experience to help design eCRF. Our medical background helps us identify areas where the eCRF design needs to reflect the same flow as medical records for ease of review and entering data.
- Oncology, neurology, immunology, and rare disease expertise. The ARG team can both identify potential challenges in advance and adjust for the nuances that are encountered in retrospective studies.
- Removal of burden from patients and sites. For patients, we implement electronic consent, telemedicine, and patient compensation. For sites, we provide data collection protocol and eSource and direct EMR/EHR access.
ARG approaches retrospective studies with our signature cross-functionality and group problem-solving.
- Team members from diverse parts of biotech and pharma industries
- Daily interaction with internal and sponsor teams
- 100% on-time submission of deliverables
- Accommodation of sponsors’ needs
- Experience with re-consent issues
- Creative solutions to avert slowdowns