MAKE SURE YOUR CLINICAL TRIAL IS ON A COURSE FOR SUCCESS
Avoid Cost Over-runs and Poor Vendor Performance
CRO & SPONSOR STAFFING
The CRO-sponsor partnership is broken. Relationships quickly deteriorate, often affecting clinical trial costs and time to market. CRS identifies the most cost-effective and risk-mitigating solutions to improve compliance and your chances of a successful outcome for your medical product.
With virtual and decentralized or hybrid trials, we have customizable blueprints to maximize technology and more patient-centric visits. We have also been brought in to rescue trials (PDF link).
Hire us for your next clinical trial team. We have a Quality Management System (QMS) and an experienced team representing project management, quality assurance, clinical monitoring, scientific writing, and medical monitoring. We fit-for-purpose data management, statistical and pharmacovigilance, if required, with our preferred providers. Or, we’ll happily work with your selected teams.
Need a functional service provider (FSP) model? We’ve got it. Or, perhaps a few CRAs to monitor as your dedicated team with your other CRO or vendors? Need a part-time contractor embedded in your company? No problem! Our team is your team. We’ve got you covered.
Our team is also well-versed in drugs, biologics and combination products, in addition to medical devices (significant risk and non-significant risk), diagnostics, IVDs, software as a medical device (SaMD), digital therapeutics and more. We assist with usability or human factors studies.
CRS indications are:
- infectious diseases
- rare disease
- bone marrow transplant
- gene and cell-based therapies
- regenerative medicine
- reproductive health
- and more
Our recent work has been across the spectrum of phase I or first-in-human (FIH), phase II-III or pivotal, and post-market or registries.
Due Diligence, RFP Process Representation and Compliance Oversight
We offer special services for sponsors who want our help vetting their partners instead. We serve on your side of the due diligence process to reduce bias in the CRO selection. We do this by:
- Developing a customized RFP document and bid grid
- Applying insider knowledge to a Top 10 Checklist for Selecting a CRO (PDF link)
- Maintaining the integrity of your CRO bid defense, selection process, and contracting phases
- Ensuring compliance in accordance with best business practices, ICH GCP E6R2, ISO14155, EU MDR, US FDA, and other international regulations
- Deterring the production of unnecessary change orders
- Contractually binding the parties to render services that were transferred under delegated tasks and responsibilities
- Developing a Quality Agreement for the parties involved
CRS Alliance Program
We’ve identified contract research organizations (CROs) and other experts who have met our strictest embodiment of quality, outstanding ethics, financial stability, deep domain know-how and technical experience, and transparency and trust within their internal and external business practices.
Lessons Learned from a Rescue Trial
A clinical trial rescue is perhaps one of the worst realities that prior decisions during the due diligence, proposal review, bid defense, and ultimate award to a CRO partner failed. What ultimately goes wrong? Well, many things, but they all boil down to the Sponsor’s internal review processes, the influence of special persons or parties, the experience of the Sponsor’s clinical operations team, the trial protocol itself, and the specifications for delegated services.
Every Sponsor’s Top 10 Checklist for Selecting a CRO
This Top 10 Checklist is a helpful starting point that can be further expanded as necessary to help Sponsors de-risk the objectives of conducting a successful clinical trial.
MEDICAL DEVICE CASE STUDY
Conducting Clinical Trials and Human Factor Studies During COVID-19 Pandemic for Novel, Non-Contact Mobile-Digital App, InteloMed TeleHealth Technology (ITT!), that Detects Respiratory and Pulse Rates through Android or iPhone Camera
Alyssa Harris, MS, Clinical And Regulatory Affairs Project Lead
Clinical Research Strategies
IS YOUR CRO CRACKING UNDER THE PRESSURE?
Rescuing trials is our specialty. Clinical Research Strategies has a team of senior project management and monitoring experts to jump in and rescue any project, large or small. We’ll repair the cracks and restore the course for your clinical trial’s success.
Let’s fix it now before it’s too late.
WE’LL HELP YOU BUILD THE RIGHT TEAM FOR A SUCCESSFUL TRIAL
We can do this together! Contact us today for a free phone consultation.