Pharmatech maintains not only an extensive network of dedicated oncology sites, but also maintains the documents that each site needs to be kept to date and open a study with expedited speed.
Pharmatech has true partnership with network centers – meaning sites have been selected to be in the Pharmatech Network, have been fully qualified, and have a master CDA, Master Clinical Research Agreement, and standard up-to-date regulatory documents on file. In addition Pharmatech has collected 320 data points on the technical capabilities of each center, satellite office, experience of each PI, Sub-I, and research staff, experience with multiple indication studies.
A proven SMO with solutions that are unique to meet the challenges of oncology trials, including AccessPPM and Just-In-Time – two programs that are so innovative that they are supported by the National Cancer Institute. AccessPPM and Just-In-Time are managed through one of the largest network in the US – 340 centers, including universities, hospitals and advanced community based centers.
- 10-day start-up for UNIVERSITIES – proprietary Just-In-Time
- 10-day start-up for HOSPITALS – proprietary Just-In-Time
- AccessPPM patient matching for biomarker patients
- Elimination of non-accruing sites
- Regulatory, budgets and contract
- Ongoing patient enrollment management
- Site enrollment support
Pharmatech’s unique ability to manage a large network and rapid 10-day activation is based on our TrialPlus web-based intranet that is utilized to communicate, match patients, manage study and regulatory documents. Pharmatech maintains the following documents on file for each site:
- Master CDA
- Master Clinical Research Agreement
- Med License, Signed CV’s
- Lab CLIA’s, lab norms and ranges
- 320 feasibility data sets on each network site
- Auto generated FDA forms, such as 1572, FDF and IRB submission
- Oversight of the day-to-day activities of all team members as well as quality, budget and timelines
- Proactive communication with the customer, team members, vendors and sites throughout the study lifecycle
- Tracking and management of predefined metrics, timelines and anticipated trends
- Identification of efficiencies and processes that improve data quality