PHARMATECH

Have any questions? Just call us at 720-917-8400

SMOElements

    Enrollment Strategy

    Pharmatech’s team uses a versatile approach to produce the most precise representation for each specific clinical research trials. Our  team’s experiences and nationwide relationships support feasibility, investigator meetings, site identification, regulatory submissions, document management and complete start-up oversight. By employing a flexible model, Pharmatech can evaluate different degrees of feasibility based on the specific needs of the sponsor.
     If a study is active, and the sponsor requires supplemental sites for accelerated study expansion, we can swiftly survey new sites for participation and qualification. With sites that can even focus on specific geographic considerations, Pharmatech can truly provide wide range or niche services.
    If the sponsor requires a detailed view of the clinical possibilities before initiating a trial, a comprehensive feasibility can be conducted to include Pharmatech-derived information on the clinical space, supplemented with site surveys to clarify and corroborate the higher level knowledge gathered.

     

    Research Network

     

    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

      Pharmatech's site network spreads all over the US. With over 340 sites in our network we are able to access patients from all indications.

      Pharmatech’s site network spreads all over the US. With over 340 sites in our network we are able to access patients from all indications.

    Project Management

     
    Oncology clinical trials are fundamentally complicated and refined. Pharmatech’s Project Management teams fully understand these issues and meet each challenge in navigating the cancer study process. With involved experience across indications, compounds and phases, our project managers construct and execute crucial milestones for each trial, while excelling at customer service and proactive communication.Project Management

    Pharmatech’s project managers have comprehensive leadership and industry expertise. Each project manager is well prepared to competently address any problems inherent to oncology studies, encourage sites, and regulate cohorts in all studies. Whether discussing a study protocol with an investigator or conducting feasibility, our project management teams are both flexible and effective. Our project managers have the ingenuity to encourage creative thinking and the authority to enact adaptable solutions, making them powerful spokespeople for our sponsors.
    Our key Project Management functions include:
    • 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