Our Services

image177

Charter Development

The development of the adjudication charter is an integral component for the successful implementation of the adjudication process for any protocol or program. The charter should be specific to the study and outline critical aspects such as committee membership, roles and responsibilities of all parties involved, endpoint definitions, source documents or data elements to be collected, and the committee decision making process. ClinEvents Adjudication can efficiently and effectively develop adjudication charters that ensure critical elements are captured in a comprehensive manner.

Adjudication Manual of Operations Development

The Manual of operations (MOP) is an essential document that serves as a guide to the operational staff detailing the finer details of the adjudication process. The MOP includes detailed information on the management of queries, translations, redactions, and changed data points to name a few. ClinEvents Adjudication has extensive experience creating MOPs and looks forward to developing your unique MOP.

Adjudication Committee Identification

ClinEvents Adjudication works with a network of physicians and AROs to provide the best make-up of the Adjudication Committee specific to your needs and therapeutic area. Regardless of the stage you are in, we can assist you with finding the specific physician experts or KOLs to meet your current needs

Adjudication Committee Contracting

ClinEvents Adjudication is experienced in contracting with committee members individually or as a group. We are happy to provide the level of service that will best meet your specific needs, whether that be rate negotiation, contract execution or invoice management.

Electronic Adjudication System Development

Web-based tools are essential for facilitating effective and efficient endpoint adjudication processes. Development of the study specific systems can be time consuming and costly if one does not have the right expertise in place overseeing the process from initiation to Go Live. ClinEvents Adjudication has several years of experience overseeing the development of electronic adjudication systems with a variety of vendors. We can successfully manage the development of the study specific system to ensure timelines are met and costs are contained.

Adjudication eCRF Development

eCRF development is an important avenue for collecting targeted data via the clinical database platform. There are a number of factors to take into account when creating the eCRFs so that site burden is reduced, source document verification is minimal,  but essential data points are collected. ClinEvents Adjudication can ensure that quality eCRFs are developed that enhance the adjudication process without adding any additional burden.

image178

Adjudication Classification Form Development

Adjudication classification form development provides the avenue for the committee members to document their assessments and notations. Development of these forms must be done in a way that allows the essential outcome data to be provided for final analysis. The forms themselves and associated concordance rules would ultimately be programmed in the adjudication system. ClinEvents Adjudication has the experience and insight to ensure these forms are developed deliberately with the clear intention of providing quality outcome data.

Adjudication Packet Assembly and Submission

Data packets must be collected for committee review regardless of the therapeutic area or type of adjudication conducted. Timely collection of the essential elements of the data packet can be quite cumbersome and convoluted. ClinEvents Adjudication has applied lessons learned from years of experience in collecting data packets to create a collection and submission process that is cost effective and timely.

Committee Meeting Coordination and Facilitation

Let ClinEvents Adjudication handle all aspects of the committee meeting coordination and facilitation. From arranging travel to booking conference rooms or scheduling teleconferences, we can take the burden of meeting planning out of your hands.

Adjudication Vendor Oversight and Management

Already have a vendor providing adjudication services? Need someone to oversee and manage the vendor to ensure the adjudication process is being executed with quality? ClinEvents Adjudication is equipped with the knowledge and expertise to oversee any adjudication related vendor to ensure your interests are being protected.

Adjudication Vendor Quality Review

Already have an adjudication vendor in place? Would you like to do spot checks to ensure the adjudication process is being executed properly? ClinEvents Adjudication can provide one time or ongoing quality reviews of your contracted vendor to ensure audit readiness.