Study Start Up Services
Cedent provides assistance in moving clinical trials through the start-up process : Our SSU groups/Consultants are equipped with latest strategies to help facilitate the startup process, drive industry-leading cycle times and offer additional flexibility in response to our client’s outsourcing demands. Our study startup services include :
|Site Feasibility analysis||Informed Consent Review|
|Identification/Qualification/selection||Electronic TMF management|
|Site activation||Independent trial committee|
Independent Trial review/monitoring committee
Early involvement of industry experts and KOLs has been recognized as a Key factor to the success of any clinical study. Knowledge and expertise they bring on board can results in high quality protocol design, study feasibility, trial design and can detect early risk signals.
Cedent has the capability to identify and set up (contracts etc.) key players for our client’s advisory committee, scientific steering committee, Data review committee and also Independent Data safety monitoring committee.We can be involved in organizing routine meetings, documentation or recording (Audi/Video) minutes for future reference.
Cedent can address the real demand for a data-driven approach to clinical trial feasibility and patient enrollment. The traditional approach to feasibility involves surveying investigators and asking for their opinions. However, this method is increasingly incomplete; investigators can provide a broad range of valuable information, such as the standard of care in their clinic or country, but relying on them for recruitment rate estimates has often proved unreliable.
In the future, leading biopharmaceutical service providers will increase their use of electronic health records to better understand the available population a protocol has defined. This will lead to more reliable estimates. Cedent already uses the Cite line commercial database, which provides a clearer picture of what other studies have achieved in terms of recruitment rates in comparable studies.
Cedent provides sponsors with a comprehensive report that details the suitability of the protocol design for implementation by research sites as a whole. Feasibility also provides accurate country and site selection data, insight into regulatory requirements, assessment of the impact of competitive trials and risk/mitigation strategy coupled with precise budget and timeline forecasts. It is a part of our commitment to provide accurate information and added value to our existing and potential clients. We also conduct physician to physician feasibility interviews as part of initial expertise opinion if required
Site identification and activation
is an important component of clinical trials and has a critical impact on subsequent trial timelines, as well as site relationships. Our best-in-class approach employs sophisticated predictive analytics to refine the site selection process to identify high-quality sites with proven track records for meeting enrollment goals. This approach is expedient and efficient and ensures the highest quality and lowest risk.