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We Remove the Barriers to Research Participation by providing:

Turnkey Clinical Trial Support

Regulatory & Compliance Oversight

Full-service management from study start-up through close-out.

Expertise in FDA, IRB, and sponsor requirements to ensure seamless adherence.
(We partner with WCG Clinical for IRB oversight)

Patient Recruitment & Retention

Dedicated Research Staff

Strategies tailored to your patient population, minimizing provider workoad.

Trained Coordinators & Support embedded within your practice.

Laboratory Data Analysis

Access to Diverse Studies

Therapeutic opportunities that align with your specialty and patient needs.

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Benefits to Your Practice & Patients

  • Expand treatment options for your patients - Give your patients access to cutting-edge therapies close to home.

  • Enhance your reputation as a leader in research - Demonstrate innovation and leadership in cancer care by offering trials that may not otherwise be available in your community.

  • Generate additional practice revenue with minimal disruption - Our team manages the trial logistics, so your clinical operations can continue without added strain on staff.

  • Gain peace of mind with expert compliance management - Rely on our seasoned regulatory and quality assurance specialists to ensure studies meet all FDA, GCP, and sponsor requirements.

  • Accelerate study start-up and enrollment - Leverage our proven processes to get trials open quickly and identify eligible patients efficiently.

  • Reduce administrative burden - We handle regulatory submissions, data entry, investigational product oversight, and audit preparation.

  • Flexible service models - Choose from full-service coordination or modular support (Regulatory, QA, Data, IP) tailored to your site’s needs.

  • Ongoing partnership and training - We help prepare your team to engage with research confidently and successfully.

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Why partner with us

Partnering with Altitude Clinical Research allows physicians and community practices to participate in industry-sponsored clinical trials without the burden of building a research department from scratch. We provide the infrastructure, expertise, and support so you can focus on caring for your patients.

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Together, we make it possible to bring high-quality clinical research into community practices, improving patient care while supporting physician and site growth.

Benefits to Participating in Research Include:

  • Expanding treatment options for patients - Provide access to new therapies, devices, or interventions before they are widely available.

  • Improve patient satisfaction and retention - Patients value innovative care and the opportunity to play an active role in advancing medicine.

  • Professional growth and reputation - Establish yourself and your practice as a trusted leader in medical innovation.

  • Additional revenue stream - Research participation creates new financial opportunities for your practice.

  • Support for staff development - Clinical research provides professional growth and training opportunities for your team.

  • Contribution to science and community health - Be part of the discoveries that improve care for future patients.

  • No need to go it alone - With and SMO partner, you can offer trials without the burden of building infrastructure, managing compliance, or hiring an in-house research department.

Why participate in research

Participating in clinical research opens doors to new opportunities both for your practice and your patients. Whether you are an oncology practice or a clinic in another specialty, research allows you to contribute to medical advancement while strengthening your practice in meaningful ways. Our team takes care of the complexities so you can experience the benefits with minimal disruption.

Administrative & Financial Services

  • Budget negotiation and coverage analysis

  • Contract management and cost-share modeling

  • Payment tracking, invoicing, and site disbursement

  • CTMS oversight and financial reporting

  • Startup and closeout cost management

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Clinical Research Coordinator (CRC) Services

  • Patient screening, eligibility, and informed consent

  • Visit scheduling and coordination of procedures

  • Source documentation and data entry

  • AE/SAE reporting and query resolution

  • Protocol training and site support

  • Follow-up and ePRO/eDiary assistance

Investigational Product (IP) Services

  • IP receipt, inventory, and accountability

  • Temperature monitoring and excursions reporting

  • Dispensing, returns, and destruction documentation

  • Pharmacy logs, chain of custody, and SOP support

  • Preparation for audits and sponsor visits

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Data Services

  • CRF/EDC data entry and query management

  • Reconciliation of source, AE/SAE, and safety data

  • Data cleaning and review prior to lock

  • Imaging (RECIST), biomarker, and specialty data tracking

  • Privacy compliance and submission timelines

Quality Assurance Services

  • Internal audits of sources, CRFs, and binder

  • Oversight of protocol adherence

  • Deviation/CAPA tracking and resolution

  • Trend analysis and corrective action planning

  • CRC training for quality improvement

Regulatory Services

  • IRB/IEC submissions and ICF development

  • Clinical Trial Agreement (CTA coordination

  • Site and staff credentialing; FDA From 1572

  • Regulatory binder creation & essential document tracking

  • Oversight of GCP compliance & delegation logs

  • Protocol deviation reporting

  • Audit/Inspection readiness and sponsor report

Our services

At Altitude Clinical Research, we provide end-to-end support for our clinical trials so physicians can focus on patients while sponsors can count on quality and compliance.

Education / Experience

  • Physician or PhD Member in good standing

  • Current Clinical research experience

  • Good Clinical Practice certification

  • Knowledge of essential Federal regulations governing clinical research

  • Participation in leadership activities

Quality Control, Quality Assurance and Regulatory

  • Adhere to good clinical practices, protection of human research participants, HIPAA, Federal, State, and Local regulations, and policies and procedures

  • Complete training as required by ACR policies, Research Bases, Research Networks, sponsors, U.S. Federal regulations, and ICH-GCP

  • Provide protocol clarifications (eligibility, data, treatment, etc.), communicate with sponsors

  • Provide a second check for the QA team on staging criteria confirmation on patients

  • Review and asses possible adverse events and provide final approval of adverse event reports

  • Sign all deviations within 24-hours of request

  • Review safety reports, action letters, updated Investigator Brochures (IB), labeling

  • Assist during audits and attend final audit closeout calls

  • Maintain oversight of all aspects of trial conduct, including patient safety, protocol adherence, and data integrity

Communications

  • Provide research staff at their clinic with pertinent updates

  • Be available to answer protocol-related questions and provide necessary signatures within 24-hours of request by local staff and the ACR main office

  • Communicate with study sponsors as needed

Organizational Operations

  • Responsible for oversight of research conducted at their specific site

  • Have familiarity with investigational agents; read investigator brochures, product inserts, or other source information

  • Assist fellow physicians/clinicians at their site in creating and maintaining a stable program infrastructure at their respective site

  • Ensures compliance and data quality

  • Identifies eleigible patients

  • Participate in local and national research conferences when possible

Principal Investigator role

The Principal Investigator (PI) is a physician or PhD member in good standing. The PI has a good understanding of clinical research, regulations governing clinical research, and their organization. The PI provides guidance and support to their team regarding protocol requirements.

If you are interested in becoming a Principal Investigator of your site, please contact us.

Contact Us
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Contact Us

Lisa Switzer, MA, CEO & Executive Director

Michael Nowicki, Director of Quality Assurance

303.777.2663 / research@altitudeclinicalresearch.org

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