PHARMATECH

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Study Startup CROElements

    Pharmatech, Inc. is a full-service, oncology focused Contract Research Organization (CRO). With over 20 years of experience, including 10 years of exclusive oncology experience, Pharmatech, Inc. is well positioned to lead you through your clinical programs. We pride our self on providing sponsors with a comprehensive portfolio of CRO services. We manage our projects through our extensive oncology network of investigators, using our proprietary enrollment solutions.

     

    DataManagement

    Pharmatech’s fundamental belief is that technological advances improve quality, speed, and efficiency of clinical trials. We combine oncology expertise with the latest clinical trial technology for efficient and effective data capture and valued-added planning for study completion. Our data team is comprised of experienced and dedicated  professionals who fully appreciate the nuances and challenges related to oncology protocols. Over the past 20 years we have fine-tuned these processes to deliver an elevated clinical trial experience that provides our sponsors with full transparency, smarter trial management and greater processes. 

    Our Data Management Department will:

    • Provide standard reports – TrialMaster® has approximately 40 standard reports to provide study metrics, open queries, audit trail information, etc.
    • Provide ad hoc reporting – Custom queries and reports can be developed on a single set of data or joined across data sets using ad hoc tool
    • Provide data listings for medical monitor as requested
    • Provide data listings on a scheduled basis, as specified by the protocol, to the DSMB
    • Conduct audit of the final database
    • Lock the database within eight weeks after the last patient has completed the study and complete submission of data entry by the associated study center

    TrialMaster®

    Pharmatech provides access to the Industry’s first in functionality eClinical management solution, TrialMaster®, developed by OmniComm Systems, Inc.  The 21 CFR Part 11 compliant solution offers unrivaled freedom to conduct clinical trials with unparalleled flexibility, ease-of-use and complete control over data. Developed using forward-looking technology based on Microsoft® .NET architecture, TrialMaster® provides a simple “drag and drop” design tool and a straightforward, logical build process that allows easy, rapid trial development.

    Pharmatech services, supports, and trains any study staff on use of the TrialMaster® software through a dedicated group of clinical research and software professionals who are committed to the success of this study. The team is also committed to ensuring that each person in the trial who touches TrialMaster® is a confident user.

    An EDC helpdesk is also available for support 24×7 that is supported by Omnicomm and Pharmatech. 

    EDC – Functionality

    TrialMaster® functionality includes many of the features found in clinical trial management systems (CTMS), such as trial management functionality for better management and support of clinical trial initiatives; safety reporting functionality to allow for SAE tracking and reporting via MedWatch or CIOMS forms; a coding solution utilizing MedDRA and WHODrug dictionaries; capability for meeting randomization requirements; and inventory tracking and management. 

    TrialMaster® Oncology Data System

    Pharmatech develops two draft versions and one final original of each study database and each associated report or other output form.

    • Define and program database according to final CRFs, including edit checks, data ranges, and WHODrug for concomitant medications, with custom dictionaries and coding/mapping conventions as required; query system initialization
    • Conduct internal validation and testing; user approval testing (UAT)
    • Develop report data shells, set up and provide remote access to sponsor data viewing portal
    • Provide planned and customized ad hoc reporting capabilities
    • Maintain database function, content, and active status through database lock date
    • Final database, reports, and validation
    • Secure intake of data into database, secure database maintenance and backup
    • Generate queries for data discrepancies; correspond with study centers and monitors for timely resolution

    Data Collection and Query Management

    Data Output for Analysis

    Data is exported from TrialMaster® via SAS Transport Files. A variety of options related to the scope of export and how data is broken down, including scheduled exports (e.g. every evening) and manual, on-demand exports are included. For analysis and reporting, the data are exported to SAS. Data derivations and analysis are done in SAS externally, to develop output listings, tables, and figures.

    SAS transport datasets, as well as other export formats (CSV, TAB PIPE), are available for download directly from TrialMaster® by a user with the appropriate permission.  The download may be accessed via the user interface in TrialMaster® and also may be transferred to a FTP site, if so desired.  The exports may be requested “on demand” or set up to be available for download on a scheduled basis (daily, weekly, monthly, or hourly if needed).  By using TrialMaster’s® unique export mapping utility, templates may be created for custom datasets (i.e. AE or Laboratory datasets only), and will be available for download in the same manner as described above.

    The OmniComm TrialMaster® System has a number of separate capabilities, including a Laboratory Normal module, on-site Sponsor training, and AE reporting.

    Data Backup

    The data is backed up nightly and stored at three different facilities:

    • Cincinnati Bell™ Technology Solutions (CBTS) Data Center
      • Production Hosting Facility – Tier3+
      • HIPAA/SAS70 Type II Compliant
      • Built within a hardened data center environment
      • Structure designed to withstand severe weather and environmental conditions, F5 tornado
    • Peak 10 Networks, Fort Lauderdale Data CenterNightly Backup: Backup Nightly to Iron Mountain (offsite storage facility)
      • Category 5 Pre-Production Center (development, testing, core business)
      • Disaster Recovery/Redundant Production Environment
      • Business Continuity Center/Hurricane Failover
    • Compliance
    • SOPs and Methodology to maintain high standards of industry compliance
    • 21 CFR Part 11 Standards

     Reporting

    In addition to data management reports, Pharmatech has developed an in-house CTMS (separate from our EDC system) that has the ability to provide both standard and ad hoc reports on patient accrual numbers, site demographic information, budget to actual numbers, and tracks sites and patients in pre-opening/pre-enrollment.  Celldex can request specific reports, but will receive the following no less than weekly during the study recruitment period:

    • Site Selection
    • Site Initiation
    • Patients in tracking
    • Enrollment
    • Screen fails

    INDSubmission

    Investigational New Drug Applications can be time-consuming, lengthy, but necessary. Pharmatech can take over this tedious process and submit the forms necessary with the up-to-date FDA requirements so that your new drug may be transported over state lines and internationally if need be.  

    Project FeasibilityAssessment

    Pharmatech’s network of sites provides it a unique ability to assess project feasibility with specific site and key opinion leader feedback. Along with specific site evaluations, we also can provide a direct and honest analysis of the protocol and any issues that we believe may arise, given our extensive experience.

    SiteRecruitment

    Pharmatech’s site recruitment comes in multiple forms. We are able to provide either traditional or accelerated enrollment methods. We 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

    RegulatoryManagement/Oversight

    Pharmatech’s Regulatory Affairs department provides complete support to sponsors. By offering both operational and strategic services, our team is knowledgeable about regulatory agencies as well as IRB/ethics committees and has a good relationship with both.Services include:

    • Regulatory submissions and liaison activities, including meeting planning, briefing package development, and meeting leadership
    • Regulatory strategy for clinical, nonclinical, and CMC activities
    • Regulatory support for advanced therapy product development, including combination products, gene therapy, and cell and tissue therapies
    • Regulatory document management and document control activities
    • Oversight of all regulatory activities
    • Single point of contact for all regulatory submissions and activities
    • Early core document preparation and approval
    • Country-specific documentation
    • Rapid review of completed site regulatory documents

    ProjectManagement

    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

    EnrollmentStrategies

    Over the last few years, Pharmatech has developed cutting-edge programs that have propelled it to the forefront of the clinical oncology industry. Working with the National Cancer Institute to establish these, Pharmatech has created three innovative enrolling programs: Just-In-Time, TrialPlus+, and AccessPPM.

    JITJust-In-Time, provides Pharmatech with the ability to open and activate a site within 10 business days, on average. By working only with sites that have pre-identified patients, Pharmatech makes non-enrolling sites a thing of the past. These sites are not exclusive to local practices either, but also include hospitals and universities.

     

    Pharmatech-TrialPlus-451x123Our industry-leading technology platform and communication tool, is entitled TrialPlus+. It is a powerful communication intranet developed for the clinical trial community and can instantaneously communicate with our 2,200 investigators and research staff.The system was designed to provide an 82% gain in trial management efficiency for site activation, regulatory document management and IRB submissions – it’s the backbone of Pharmatech’s 10-day site activation timeline.

    Pharmatech’s newest innovation: AccessPPM or Accessing Personalized, Precision Medicine is an industry AccessPPMrevolutionizing, IRB approved molecular screening program designed to match patients to your studies at a genetic level and mitigate the cost and time associated with recruiting patients into biomarker driven clinical trials including this project. It’s Pharmatech’s priority screening protocol that stratifies patients into clinical studies and eliminates the cost and time of screen fails, slow recruitment, and non-enrolling sites. It addresses one of the most demanding challenges in clinical trials: identifying patients who have the same biomarkers that are targeted by study drugs.

    Medical Monitoring

    Pharmatech’s Medical Monitoring department employs a core group of licensed and board-certified, in-house clinical research physicians supplemented with a  physician consultant who provides specific therapeutic expertise. This combination of highly skilled physicians offers a cost-effective approach to day-to-day trial activities, as well as the therapeutic expertise of practicing research physicians with state-of-the-art training. Whether the sponsor requests initial study design, protocol development, full study execution or select medical task assistance, our team tailors each program’s medical needs with the desired medical support.

    Our medical monitoring services include:

    • Protocol development and consulting
    • Therapeutic consulting
    • Medical review of informed consent and CRF design
    • Development of individual study medical monitoring plans
    • Investigator brochure development
    • Site selection and enrollment enhancement solutions
    • Key opinion leader network development
    • Scientific and medical support for project management teams and sites
    • Laboratory data review
    • Medical data coding and review
    • 24-hour on call medical monitoring for protocol queries and site support, medical/safety issues
    • Regulatory agency support and interface
    • End of study tables and listings review and scientific manuscript drafting/review

    MedicalWriting

    Pharmatech fully comprehends the importance that medical writing plays in each study— whether it’s protocols or package inserts — and our objective is to create clear, concise, and polished clinical documents.We offer medical writing as a component of our full-service CRO program. Our medical writers have the experience and knowledge to produce expertly written documents. Working closely with our project teams, Pharmatech’s medical writers ensure accuracy and consistency.

    Our medical writing services include:

    • Clinical study reports
    • Protocols
    • FDA briefing documents
    • Clinical and summary sections of Common Technical Documents (CTDs)
    • Clinical and summary sections of New Drug Applications (NDAs)
    • Investigational New Drug Applications (INDs) and Annual Updates
    • Biologic License Applications (BLAs)
    • Investigator’s brochures
    • Informed consent forms
    • Abstracts, posters and journal articles
    • Executive summaries for efficacy or safety
    • Patient narratives
    • Package inserts

    Pharmacovigilance

    Because leaving medical reviews for the end of a trial leads to delays in locking and, sometimes, the discovery of unexpected inconsistencies, we recommend frequent and ongoing medical reviews and critical eCRF reviews.  This will enable issues to be identified early and acted upon quickly. Allowing for cross checks in the eCRF database that link medical history/AE/concomitant medications data ensures that this critical data is captured correctly, as does checking disease status throughout the study. SAE and AE reconciliation will be perform continuously throughout the study.

    QualityAssurance

    Pharmatech’s quality management processes are essential to all aspects of our business. Our Quality Assurance (QA) department performs regular quality assessments of our services to ensure compliance with FDA and international GCP regulations, ICH, ISO, our SOPs and our commitment to customers. 

    Founded in 1987 and headquartered in Denver, Colorado, Pharmatech is a US based oncology-specific CRO and SMO with a broad range of oncology-focused service offerings. The company is uniquely positioned to manage the indication-specific challenges related to oncology CRO and SMO projects. The company brings the experience of managing hundreds of oncology projects, 5 of which were recent melanoma studies. As a part of its culture, Pharmatech focuses on the most challenging aspect of oncology projects – enrollment and timeline management. It’s no wonder the company has developed a reputation for rescuing trials.

    • Pharmatech is an oncology focused CRO
    • Innovative AccessPPM program – the world’s most powerful patient recruitment tool developed to overcome the challenges of biomarker driven clinical trials.
    • Unique and exceptional ability to open/activate university sites within 10 business days using our Just-in-Time approach
    • Contingency planning and risk mitigation strategies
    • Projects are managed as a true CRO and Sponsor team
    • Fully transparent project management philosophy
    • Our sites and processes make us the cost-effective CRO solution