Our Services
The clinical trial process is extremely complicated and presents a major barrier to physicians who might otherwise be interested in clinical research. NOLA-CTC understands your time and resource limitations, so we manage all of the regulatory and administrative tasks associated with the clinical trial process, allowing you to focus your attention on the care of your patients. We provide services and support in the following areas:
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​Preliminary Site Assessment
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Primary Liaison with Sponsor/(CRO)
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Staff Training and Credentials
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Project Development
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Contract and Budget Negotiations
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Accelerated Study Start-Up
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SOP Development
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Informed Consents
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IRB applications
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Recruitment and Retention
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Essential Documents and eTMF
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SAE and Safety Reports
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Reguatory Compliance
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Continued Support
Clinical Trial Management
In clinical research, information flows in a non-linear fashion. Time-sensitive requests for documents, data, and signatures come from many directions, often all at once. Missing a single document, or even a data point, can interrupt the entire process. Let NOLA-CTC's experienced, dedicated clinical research professionals manage your site's administrative and regulatory needs.
Role of the Sponsor
"A clinical study sponsor refers to an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study or trial. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator."
Role of the SMO
An SMO is a company that provides clinical trial management services to sponsors, CROs and clinical investigators at a research site. Services include startup, monitoring, and closeout responsibilities. SMOs help sponsors streamline their administrative processes while ensuring that all regulatory requirements are met.
Role of the CRO
"A Contract Research Organization (CRO), sometimes known as a Clinical Research Organization, is an organization contracted by another company to take the lead in managing that company’s trials and complex medical testing responsibilities."
Role of the Research Site
The role of a research site is to enroll patients into clinical trials, while ensuring patient safety, adherence to the protocol, data integrity, and compliance with all regulatory requirements. At the site, the Principal Investigator is responsible for all aspects and obligations associated with clinical research, but they may delegate responsibilities to other qualified individuals.