Data Backlog Recovery
High-volume SDV/SDR, query generation, outstanding-data assessment, prioritization, and structured recovery support.
PHASE I • FIRST-IN-HUMAN • HEMATOLOGY • ONCOLOGY
Specialized intervention when routine monitoring isn’t enough.
Acuity Clinical Partners supports complex, high-value clinical trial sites facing data backlogs, compliance concerns, intensive monitoring demands, and operational risk.
10+ YearsClinical-trial experience
20+ StudiesPhase I / First-in-Human experience
~150 Pages/DayIntensive SDV & source review assignments
Phase I oncology expertise. Clinical trial recovery. Clinical operations leadership.
TRIAL RESCUE & RECOVERY
When high-enrolling sites become high-risk sites.
Trial rescue requires more than adding monitoring hours. Acuity focuses effort on the issues most likely to affect subject safety, data integrity, compliance, and sustainable site performance.
Compliance Recovery
Focused attention to protocol execution, documentation, safety reporting, investigational product oversight, and recurring operational concerns.
Critical-Site Engagement
Experienced support for high-enrolling and KOL-led sites where productive relationships must be maintained while performance issues are addressed.
AssessDefine backlog, risks, stakeholders, and operational constraints.
PrioritizeSeparate trial-impacting issues from lower-value noise.
EngageEstablish ownership, expectations, and workable communication.
RecoverDrive measurable progress toward sustainable execution.
EARLY-PHASE EXPERTISE
20+ Phase I and First-in-Human studies.
Deep experience in complex hematology and oncology programs, complemented by broader Phase I–III clinical-development and clinical-operations experience.
Experience includes immunotherapy, chemotherapy, targeted therapy, high-enrolling sites, KOL investigators, and demanding early-phase monitoring environments.
Selected drug-development experience includes trials involving pembrolizumab, tislelizumab (Tevimbra), and zanubrutinib (Brukinsa). Product names are referenced solely to describe professional trial experience; no affiliation or endorsement is implied.
CLLCMLAMLMDSMultiple Myeloma
B-Cell Lymphoma / NHLHodgkin LymphomaNSCLCSCLC
Head & Neck CancerHCCRenal Cell CarcinomaProstate Cancer
Breast CancerColon CancerEsophageal CancerBrain Metastases
Advanced Solid Tumors
REPRESENTATIVE EXPERIENCE
Selected complex-site assignments.
Examples are intentionally anonymized to protect sponsor, institution, investigator, and protocol confidentiality.
CASE 01Compliance Recovery
High-enrolling metastatic NSCLC site
A well-known institution participating in a metastatic NSCLC trial was the study’s second-highest enrolling site. A significant operational backlog and internal audit findings raised serious concerns regarding site performance and readiness for potential regulatory inspection.
Outcome
The site was brought back into compliance, remained active, and continued contributing enrollment over the following year. The study later contributed to an evolving standard-of-care approach in metastatic NSCLC.
CASE 02High-Volume Phase I Support
First-in-Human Phase I/II solid-tumor site
Repeated deployment to high-enrolling, high-priority sites requiring intensive monitoring and data-quality support. Representative experience includes a site that enrolled approximately 30 patients into a First-in-Human Phase I/II advanced solid-tumor study.
Scope
Assignments have included approximately 150 pages of source review per day, combining SDV with diligent SDR and query generation for potentially missing adverse events, concomitant medications, and pertinent medical history.
THREE CORE CAPABILITIES
From intensive site intervention to management-level leadership.
Trial Rescue
Data backlog remediation, compliance recovery, site re-engagement, risk-focused intervention, and support for strategically important sites.
Early-Phase Monitoring
On-site and remote monitoring, SDV/SDR, safety review, query resolution, IP oversight, essential-document review, site qualification, initiation, interim monitoring, and closeout.
Clinical Operations Leadership
Project and risk management, vendor oversight, cross-functional leadership, resource and budget awareness, study execution, client communication, and operational escalation.
GEOGRAPHY & AVAILABILITY
Support aligned to the level of service required.
Monitoring & Trial Rescue
Available for U.S.-based on-site and remote monitoring, intensive SDV/SDR, data-backlog remediation, compliance recovery, and critical-site support.
Management-Level Services
Available for clinical operations leadership, project management, risk management, vendor oversight, cross-functional coordination, and strategic trial-recovery support across U.S. and international programs.
FOUNDER & PRINCIPAL CLINICAL CONSULTANT
Morten Fornaess, DPM
More than a decade of clinical research experience spanning clinical monitoring, site management, clinical operations, and project leadership.
Experience across the clinical-trial lifecycle includes site feasibility and qualification, initiation, enrollment, monitoring, risk management, regulatory and quality oversight, safety reporting, source data verification, issue escalation, and study closeout.
Prior roles include Senior Clinical Research Associate, Clinical Research Manager / Project Manager, and Project Leader with major global CRO organizations, with experience in cross-functional leadership, vendor management, client relationships, budgets, resources, quality, and study performance.
Doctor of Podiatric MedicineKent State University
BS, Biomedical SciencesWestern Michigan University
Immunology – Immuno-OncologyHarvard Medical School Certificate of Achievement
PRINCE2 FoundationProject Management Certification
START A CONVERSATION
Is a critical trial or site becoming difficult to recover?
Share the situation at a high level. Acuity can discuss the operational challenge, urgency, geography, and whether focused support is a fit.
contact@acuityclinicalpartners.comPlease do not submit patient-identifiable information, protected health information, or confidential/proprietary study information through this form.