No matter the size of your organization, when it comes to clinical trial disclosure you sometimes need more than software alone. In addition to providing the top global clinical trial disclosure and transparency management technology, we offer the insights necessary to make solid business decisions and hands-on assistance that frees your staff to focus on the bigger picture.
Whether you’re starting from scratch or optimizing existing disclosure efforts, your organization can benefit from a third-party perspective. Our disclosure experts, with more than 50 years of combined experience, conduct various assessments to see where you stand, what needs to be corrected, and what needs to be in place so your organization can stay on top of compliance.
Disclosure Compliance Review
Data-driven review and analysis of past and current disclosure compliance, based on U.S. and EU regulatory requirements.
Policy & Process Assessment
Evaluation of organizational policies and SOPs, guidelines & checklists to identify opportunities, address compliance gaps and recommend changes.
Operating Model Development
A thorough examination of disclosure operations to document stakeholders and responsibilities, develop processes and timelines, and establish metrics for compliance monitoring.
If your disclosure team is like most, your resources are stretched thin. Our disclosure team works as an extension of your own staff. We do it all, from protocol registration through results posting. And our services are scalable to meet your organization’s unique needs.
Authoring, reviewing, editing, approving and publishing clinical trial application and disclosure data, resolution of ClinicalTrials.gov comments, plus ongoing maintenance of registrations.
Preparation of study documents including final study protocol, final statistical analysis plan [SAP] and amendments, disclosure on ClinicalTrials.gov, and preparation of XML upload for EU trials.
Plain-Language Summaries (PLS)
Author the summary and post to TrialScope Results Summary Portal; language translation and graphic design services also available; summaries provided for local affiliates as needed.
Development of rule sets, redaction/anonymization of full submission, and preparation of additional package documents, incorporating changes as required.