[ Feasibility & Environmental ]
[ Assessment ]
[ Adding Value to Clinical Trials ]
[ Clinical & Medical ]
[ Science Liaison ]
[ Patient Concierge
[ Clinical Research Monitoring ]
[ Trial & Site Startup ]
[ Site Payment & Budgeting ]
[ Safety & Pharmacovigilance ]
The first step for connecting rare disease patients to orphan drug therapies is to understand its value-chain and the involved stakeholders. OrphanDC offers a tailor-made Feasibility & Environmental Assessment service, focused on providing an integrated process for trial acceleration with the best environment for our clients’ performance.
Adding Value to
Clinical Trials Operations' key point is ensuring patient mapping, regulatory strategic insights & actions, timely recruitment, and data quality throughout a smooth process. In addition, OrphanDC liaises with our clients, stakeholders, and the region's uniqueness, achieving all trials’ full potential.
Clinical & Medical Science Liaison
and Patient Support
A field team with vast experience in different healthcare areas represent OrphanDC’s Clinical & Medical Science Liaison & Patient Support area. We develop and implement strategic activities related to our clients’ projects and needs.
OrphanDC operates a Patient Support and Travel Management Full-Service Program. OrphanDC’s team locates potential subjects who meet the trial’s criteria by working with their respective KOLs, and our patient support team offers comprehensive help regarding legal documentation (passport/visa), travel arrangements, treatment and trial compliance, working not only as accompanying nurse, but also as a concierge to our client’s patient.
OrphanDC brings expertise and local understanding from the pre-feasibility stage, applying it until trial closeout and maintenance.
We aim to foster site engagement by promoting qualitative enrollment while minimizing screening failure.
“We anticipate gaps and bottlenecks with a problem-solving approach.”
OrphanDC operates a multilayered strategy for site support (not only training the clinical team, the sites, and all stakeholders directly involved in the trial but also proactively dealing with the heavy lifting tasks).
From regulatory and ethical submissions to contract negotiations and site training, we always highlight and put the trial on the spot.
“We balance being agile, flexible, and proactive while always respecting the process.”
OrphanDC understands how crucial it is to maintain a smooth payment and budgeting process.
By acting diligently and responsively, we implement a robust framework based on agility while always observing the proper guidelines.
“On an engaged site, the team should be focused on their core activities, not bureaucracy and red tape.”
OrphanDC has implemented its safety and pharmacovigilance department in-house to provide a wide range of services faster and more effectively.
We perform all safety regulatory submissions (from Phase I to Phase IV, from data entry to case closure), covering a multitude of actions such as assessments, regulatory and ethical submissions, reporting, and follow-up meetings, among others.