Key Aspects of Our CRO Project Management Services
Professional Clinical Research Associates (CRAs)
Our team of professionally qualified CRAs manages the protocol design, study setup, and oversight of clinical trials, ensuring adherence to the highest standards.
Comprehensive Project Management
We offer a complete CRO project management service, encompassing study reporting, data processing, and overall coordination of the clinical trial process.
Clinic Selection and Training
Our CRO service includes selecting and training clinical sites, ensuring that they are fully prepared and equipped to participate in the trial.
Digital and Electronic Systems
We employ a digital environment for efficient tracking and reporting of study results and quality control. Our electronic eCRF (Electronic Case Report Form) system facilitates convenient management of study documents.
Regulatory Compliance and Permits
We handle the acquisition of necessary permits and contracts on behalf of your company, ensuring compliance with regulatory requirements in various markets.
Adherence to GCP/ISO 14155 Standards
Our CRO project management service ensures that clinical trials are conducted in accordance with Good Clinical Practice (GCP) guidelines and ISO 14155 standards. This guarantees the reliability of trial results, protects trial subjects’ rights, and safeguards their safety and well-being at all stages.
Regulatory Acceptance and Data Confidentiality
By adhering to international standards, we ensure that trial results are accepted by regulatory bodies in the EU and US. We maintain the confidentiality of trial subjects’ data and ensure the traceability and proper documentation of all study records.
Why Choose MDS Denmark for CRO Project Management?
Expertise in Clinical Trials
Our project managers and CRAs bring deep experience in handling clinical trial operations across therapeutic areas and study types, ensuring that your study is conducted efficiently and effectively.
Cost-Effective and Transparent
From startup to database lock, our CRO project management services ensure seamless collaboration between sponsors, sites, and regulatory bodies. We offer a cost-effective and transparent service compared to our competitors, without compromising on quality or compliance.
Global Compliance
Our strict adherence to international standards ensures that your clinical trials meet global regulatory requirements, enhancing the credibility and acceptance of your study results.
STREAMLINING YOUR CLINICAL TRIALS FOR SUCCESS
With MDS Denmark’s CRO project management services, you gain a reliable partner who ensures that your clinical trials are conducted with the utmost professionalism and in line with international standards. Our comprehensive approach to clinical trial management facilitates the successful execution of your studies from start to finish.