Clinical Study Management
We deliver a collaborative approach provided by a dedicated team.
Experience and Quality Matter
The experience and quality of your project manager and CRAs can dramatically affect the outcome of your clinical trial, both in cost and in data quality. Simply put, there’s no substitute for hands-on experience, training and strong communication.
With WCCT and Medelis, you receive a focused project manager to be your single point of contact throughout your study. Our project managers and CRAs meet specific standards to ensure you’re getting the right experience on your clinical study. We provide a dedicated study management team for your study, avoiding the conflicted commitment that comes from shared resources.
Rigorous Standards for Operational Excellence
When it comes to experience, we’re not a training ground; our oncology team is held to the strictest standards of training and experience:
- Clinical operations team members have at least 10 years of hands-on experience managing clinical trials, and our average length of experience is 15 years.
- Our medical monitors are physicians and former investigators with hands-on research experience in managing and evaluating safety in clinical trials.
- Eighty percent of the CRAs are nurses with oncology training (many are former oncology study coordinators).
We also apply the rigorous standards used for our oncology studies to other therapeutic areas. This enables us to anticipate potential issues, and recommend solutions to keep your study on budget and on track.
Our study management services include:
- Internal and external team management
- IND gap analysis
- Vendor management
- Timeline management
- Budget management
- Project reporting
- Risk management
Our operational expertise gives you the comfort of having a highly skilled team at your disposal and a proactive partner managing your study.
While some CROs only use in-house CRAs, we use a blended approach of in-house FTEs and full-time contractors. The best CRAs are in high demand and are able to work on contract instead of in-house. By developing long-term relationships with these highly skilled monitors, we’re able to deliver dedicated resources for your study to ensure the integrity of your research.
All of our CRAs have deep hands-on, therapeutic-specific clinical trial management experience with 80% being oncology-focused. Many have been study managers themselves. This enables us to take a proactive approach to quickly and effectively resolve the nuances that occur during the course of a typical study.
Medical Monitoring and Safety
Medelis also provides drug-safety services to manage the collection and reporting of serious adverse events. We can define the overall procedures for the collection, evaluation and reporting of SAEs, providing 24-hour assistance and immediate reporting from the site to you.
Board-certified specialists are also available to offer medical management and oversight on your behalf, working closely with site investigators and your own experts to assure the greatest safety for patients.
Document Preparation and Production
From study setup to database lock, be comfortable knowing that your entire team will proactively manage every element of your study, minimizing risks to deliver consistent and quality data.
Medelis can assist in creating, reviewing and approving all clinical trial documentation, from site-specific informed consent documents to all original regulatory documentation, from FDA to IRB to IRS documentation.