MakroCare is focused on your needs, providing comprehensive CRO services to support clinical studies. As stand-alone solutions or part of a complete Device development, our specialists deliver a full range of support services for a wide variety of study types − always working with you to deliver the complementary CRO services that accelerate your program, meet your milestones, and ensure compliant, on-time regulatory submissions for your devices.
Our comprehensive CRO services complement preclinical and clinical capabilities to deliver a complete solution. As stand-alone offerings, or part of an integrated program, we are committed to providing accurate, rapid, and reliable results.
We can help you navigate the program development landscape and prepare a study design that best accommodates your product specifications and goals, while meeting the requirements of corresponding regulatory authorities. Our Technical and clinical staff works in close collaboration to define your program needs, prepare investigational plans, and ensure successful transitions between R&D and clinical, for all types of devices.
We work with you to translate your clinical study design into the protocols and technical execution that drive effective study conduct for small and large molecules. Our CRO services team includes knowledgeable therapeutic experts, always attuned to program needs.
High quality Trial management is key to the success of your device programs, and is an integral part of our CRO services. Our Trial project management team has strong expertise in a wide range of study types and therapeutic areas devices and diagnostics, and will oversee every aspect of your study.
We deliver comprehensive data management services using efficient and meticulous processes, coupled with our proprietary sofware technologies to ensure your clinical trial data is managed with compliance and accuracy.
MakroCare’s CRO services include a team of highly experienced, well-trained CRAs to expertly oversee all the relevant aspects related to conduct of your clinical research. Their individualized attention ensures compliance with your protocol and GCP as well as securing patient safety and data integrity. Our CRAs are dedicated to monitoring all the details of your study, from initiation to final close-out, including the following:
We facilitate and expedite delivery of our comprehensive suite of Research Support Services through a Full-Time Equivalent agreement (FTE) option that offers maximum flexibility, and ensures you have consistent access to our experts through the different phases of your drug development program.
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Medical Devices CRO Services – Clinical Research Organization (CRO) for Medical Device Clinical Trials (new product or PMCF).