Aspen Clinical Research

The Aspen Advantage
A phase I unit cannot be wholly efficient if its business model is only partly effective. Aspen Clinical Research focuses on three vital aspects of clinical research to optimize success at all levels and minimize expensive delays in every stage of every trial.
Technology and Resources
Aspen Clinical Research’s management team has over 30 years of combined research experience in developing, operating, and conducting the strategic processes and S.O.P’s used to provide the highest quality of research using solid systems and methodologies that prevent common problems, improve efficiency, and limit cost.
Staff and Experience
Multi-specialty trained and experienced, our staff mixes excellent bedside manner with a thorough dedication and clinical skill to doing the job right the first time, and every time.
Flexibility and Capability
Whether it’s amending the contract, adding new cohorts, expanding the I&E’s, or dealing with any other new development, we pride ourselves on our ability to respond to every situation in real time and with real solutions. Our in-house contract, regulatory, and quality assurance department expedite all phases of study start-up and operations.

Technology and Resources
We approach our choices of technology with a clear understanding of the difference between meaningless new gadgetry and true upgrades. From the temperature controls on our Refrigerators/Freezers to our ECG telemetry system, our systems are web-based, constantly backed up, and proven to minimize the chance of protocol deviations.
*Our Criticare ECG central surveyor telemetry system enables us to run QTC thorough ECG trials and cardiac-safety testing in real time. All data is captured digitally, backed up daily, and formatted for the FDA digital ECG warehouse.
*We house a USP 797-compliant pharmacy and clean room with the ability to do high-risk compounding.
*Our facility is monitored and secured by a web-based, remote-access, key-fob access system. This system is extremely robust in its capabilities, including the high-security vault setting placed on the pharmacy and clean room.
*We have a growing support network of physicians in the community who continually add to our multi-specialty database of over 65,000 subjects that can be searched electronically by indication and other measurable inclusion/exclusion critieria.
*All refrigerators and freezers housing drugs or samples are connected to a central dickson system, which monitors and logs temperatures and humidity twenty-four hours a day.
*Our 800 square foot surgical suite comes radiographic certified with full C-arm fluoroscopy, in wall suction, full ACLS crass cart with defibrillator, and other amenities to complete same day surgical procedures prior to dosing all in-house.
*We also have a non-emergency transportation system to provide assisted wheelchair and stretcher transport service to our facility to ensure subject access to visits and procedures and to aid caregivers or other personal care assistants in appropriate and safe transportation.
Staff and Experience
Any technologies and methodologies we put into place would be useless without a highly effective team of experienced personnel. Cross-trained and professional, the Aspen staff is committed to pursuing results and timelines with a tenacity that most sites can’t match. Our greatest strengths include:
*Multi-specialty trained staff capable of dealing with special populations in a range of therapeutic areas, and experience with PK and efficacy trials and FIH.
*A full time, on-site CMO that can review information and make decisions on the spot.
*A highly experienced and extremely knowledgeable COO that keeps our conduct running smoothly and without fail.
*24-hour personnel during in-patient visits, including RNs, PMTs, and RAs.
*An in-house advertising and recruitment department that connects patients to studies.
*Well-qualified and highly motivated Study Managers and RAs with an excellent bedside manner that puts patients at ease while maintaining real-time data integrity.
*Drive and initiative to complete trials on schedule, even if unforeseen complications arise mid-study, and a team-based work ethic that keeps things moving.

Flexibility and Speed
The world would be a great place if clinical research always ran smoothly and exactly as planned, but if you’ve been in the industry for any length of time, you know that things usually don’t work out that easily. That’s why we pride ourselves on our flexibility and speed in all of these vital areas:
*We run both short-term and long-term studies, PK and efficacy, FIH, as well as in-patient, out-patient, healthy, and special population trials.
*Our regulatory department is small but mighty, with exceptional organization and responsive staff that will process amendments in the shortest time possible.
*Regulatory works with Central IRB that is capable of 24-hour turnaround, so changes are usually made within a week—or less if needed.
*With a 20,000 sq. ft. facility, we’re not small, but we’re not big enough to get mired down in bureaucracy, either. Our departments all talk to each other because our offices are down the hall from each other, not floors or states away. That means that decisions get made and problems get solved swiftly.
*We integrate well with both small biotechs and big pharma. We have extensive experience in multiple therapeutic areas with the biggest names in the industry, and we’ve run numerous trials for start-ups and other smaller facilities.
*We can start up quickly. From first contact to study completion, we’re both smooth and fast. Did another site fail to deliver? Do you need to get the ball rolling before the end of the year? We’ll jump in feet first and hit the ground running.

Patch Trials
Aspen Clinical Research and our partners offer a full suite of transdermal patch study services. Our facility providesfull screening capacity, state-of-the-art recruiting technology, with access to an internal database of more than 65,000 healthy subjects, and patch evaluators with years of dermatology and adhesion evaluation experience.
Our ability to conduct patch studies throughout Utah combined with our fast turn-around from protocol to data delivery achieves high quality HRIPT, Photoallergy, Phototox, and Cumulative Irritation patch study data that will exceed your timeline experience with other contract facilities.
For more detailed information or to schedule a site selection visit please contact Ian Dawe, RN, BSN, V.P. Business Development, at Aspen Clinical Research or via email iand@aspenclinicalresearch.com
Therapeutic Expertise
In our years of operation, we have gained experience with many pathologies. Our regular physician staff oversees the majority of our trials, from healthy to diabetic to dermatology, but we also have many doctors on hand in an array of specialties. This means that we can put the best know-how and experience in charge of every study.
We have experience in the following therapeutic areas:
Pain: IV, PO, Topical, & TENS
Diabetic Neuropathy with/without Mechanical Hypersensitivity
Chronic Pain
Break Through Pain
Post Herpetic Neuralgia
Acute Pain Models-Wisdom Tooth Extraction/Bunionectomy
Osteoarthritis
Rheumatoid Arthritis
Chronic Low Back Pain
Pain Addiction
Migraines

CNS:
Schizophrenia-Antipsychotic and Neuro-Cognitive Assessments
Schizoaffective- Antipsychotic and Neuro-Cognitive Assessments
Bipolar / Mood Disorder
ADD / ADHD- Adults, Adolescents 12-17, and Children 7-11
Major Depressive Disorder-Adults, Adolescents 12-17, and Children 7-11
Anxiety
Epilepsy-Seizure
Alzheimers- Neurocognitive and Imaging Assessments
Restless Leg Syndrome
Sleep / Insomnia with PSG’s

Women’s Health:
Contraception
HPV
Urinary tract Infections
Iron Deficiency Anemia with Abnormal Uterine Bleeding
Osteoporosis
Overactive Bladder

Others:
Cardiovascular Health
Hypertension
Food Allergies
Asthma
Obesity
Diabetes Type I and II (Hyperglycemia / Foot Ulcers / Retinopathies)
Cholesterol / Lipidemia (Hypercholesterolemia / Hypertriglyceridemia)
Glaucoma
Gastric Esophogeal Reflux Disorder
Constipation
Pneumonia
Influenza
Pediatric / Adult Vaccinations
Nocturia

Site Study Resources:

-Early Phase:
-PK/PD Studies
-Safety / Efficacy
-SAD, MAD, MTD
-Inpatient / Outpatient
-Phase I-IV
-FIH, Phase 0-IIa
-PH Monitoring
-CGMS Testing
-24 hr. Telemetry
-24 hr. PK/PD/Pharmacogenetics
-Drug to Drug Testing Trial with Multiple Cocktails
-Neuropsychiatry Testing
-QTc Trials
-TET and Intense ECG Trials
-Bioavailability/Bioequivalence Trials





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The Aspen Advantage A phase I unit cannot be wholly efficient if its business model is only partly effective. Aspen Clinical Research focuses on three vital aspects of clinical research to optimize success at all levels and minimize expensive delays in every stage of every trial. Technology and Resources Aspen Clinical Research’s management team has over 30 years of combined research experience in developing, operating, and conducting the strategic processes and S.O.P’s used to provide the highest quality of research using solid systems and methodologies that prevent common problems, improve efficiency, and limit cost. Staff and Experience Multi-specialty trained and experienced, our staff mixes excellent bedside manner with a thorough dedication and clinical skill to doing the job right the first time, and every time. Flexibility and Capability Whether it’s amending the contract, adding new cohorts, expanding the I&E’s, or dealing with any other new development, we pride ourselves on our ability to respond to every situation in real time and with real solutions. Our in-house contract, regulatory, and quality assurance department expedite all phases of study start-up and operations. Technology and Resources We approach our choices of technology with a clear understanding of the difference between meaningless new gadgetry and true upgrades. From the temperature controls on our Refrigerators/Freezers to our ECG telemetry system, our systems are web-based, constantly backed up, and proven to minimize the chance of protocol deviations. Our Criticare ECG central surveyor telemetry system enables us to run QTC thorough ECG trials and cardiac-safety testing in real time. All data is captured digitally, backed up daily, and formatted for the FDA digital ECG warehouse. We house a USP 797-compliant pharmacy and clean room with the ability to do high-risk compounding. Our facility is monitored and secured by a web-based, remote-access, key-fob access system. This system is extremely robust in its capabilities, including the high-security vault setting placed on the pharmacy and clean room. We have a growing support network of physicians in the community who continually add to our multi-specialty database of over 65,000 subjects that can be searched electronically by indication and other measurable inclusion/exclusion critieria. All refrigerators and freezers housing drugs or samples are connected to a central dickson system, which monitors and logs temperatures and humidity twenty-four hours a day. Our 800 square foot surgical suite comes radiographic certified with full C-arm fluoroscopy, in wall suction, full ACLS crass cart with defibrillator, and other amenities to complete same day surgical procedures prior to dosing all in-house. We also have a non-emergency transportation system to provide assisted wheelchair and stretcher transport service to our facility to ensure subject access to visits and procedures and to aid caregivers or other personal care assistants in appropriate and safe transportation. Staff and Experience* Any technologies and methodologies we put into place would be useless without a highly effective team of experienced personnel. Cross-trained and professional, the Aspen staff is committed to pursuing results and timelines with a tenacity that most sites can’t match. Our greatest strengths include: Multi-specialty trained staff capable of dealing with special populations in a range of therapeutic areas, and experience with PK and efficacy trials and FIH. A full time, on-site CMO that can review information and make decisions on the spot. A highly experienced and extremely knowledgeable COO that keeps our conduct running smoothly and without fail. 24-hour personnel during in-patient visits, including RNs, PMTs, and RAs. An in-house advertising and recruitment department that connects patients to studies. Well-qualified and highly motivated Study Managers and RAs with an excellent bedside manner that puts patients at ease while maintaining real-time data integrity. Drive and initiative to complete trials on schedule, even if unforeseen complications arise mid-study, and a team-based work ethic that keeps things moving. Flexibility and Speed* The world would be a great place if clinical research always ran smoothly and exactly as planned, but if you’ve been in the industry for any length of time, you know that things usually don’t work out that easily. That’s why we pride ourselves on our flexibility and speed in all of these vital areas: We run both short-term and long-term studies, PK and efficacy, FIH, as well as in-patient, out-patient, healthy, and special population trials. Our regulatory department is small but mighty, with exceptional organization and responsive staff that will process amendments in the shortest time possible. Regulatory works with Central IRB that is capable of 24-hour turnaround, so changes are usually made within a week—or less if needed. With a 20,000 sq. ft. facility, we’re not small, but we’re not big enough to get mired down in bureaucracy, either. Our departments all talk to each other because our offices are down the hall from each other, not floors or states away. That means that decisions get made and problems get solved swiftly. We integrate well with both small biotechs and big pharma. We have extensive experience in multiple therapeutic areas with the biggest names in the industry, and we’ve run numerous trials for start-ups and other smaller facilities. We can start up quickly. From first contact to study completion, we’re both smooth and fast. Did another site fail to deliver? Do you need to get the ball rolling before the end of the year? We’ll jump in feet first and hit the ground running. Patch Trials Aspen Clinical Research and our partners offer a full suite of transdermal patch study services. Our facility providesfull screening capacity, state-of-the-art recruiting technology, with access to an internal database of more than 65,000 healthy subjects, and patch evaluators with years of dermatology and adhesion evaluation experience. Our ability to conduct patch studies throughout Utah combined with our fast turn-around from protocol to data delivery achieves high quality HRIPT, Photoallergy, Phototox, and Cumulative Irritation patch study data that will exceed your timeline experience with other contract facilities. For more detailed information or to schedule a site selection visit please contact Ian Dawe, RN, BSN, V.P. Business Development, at Aspen Clinical Research or via email iand@aspenclinicalresearch.com Therapeutic Expertise In our years of operation, we have gained experience with many pathologies. Our regular physician staff oversees the majority of our trials, from healthy to diabetic to dermatology, but we also have many doctors on hand in an array of specialties. This means that we can put the best know-how and experience in charge of every study. We have experience in the following therapeutic areas: Pain: IV, PO, Topical, & TENS Diabetic Neuropathy with/without Mechanical Hypersensitivity Chronic Pain Break Through Pain Post Herpetic Neuralgia Acute Pain Models-Wisdom Tooth Extraction/Bunionectomy Osteoarthritis Rheumatoid Arthritis Chronic Low Back Pain Pain Addiction Migraines CNS: Schizophrenia-Antipsychotic and Neuro-Cognitive Assessments Schizoaffective- Antipsychotic and Neuro-Cognitive Assessments Bipolar / Mood Disorder ADD / ADHD- Adults, Adolescents 12-17, and Children 7-11 Major Depressive Disorder-Adults, Adolescents 12-17, and Children 7-11 Anxiety Epilepsy-Seizure Alzheimers- Neurocognitive and Imaging Assessments Restless Leg Syndrome Sleep / Insomnia with PSG’s Women’s Health: Contraception HPV Urinary tract Infections Iron Deficiency Anemia with Abnormal Uterine Bleeding Osteoporosis Overactive Bladder Others: Cardiovascular Health Hypertension Food Allergies Asthma Obesity Diabetes Type I and II (Hyperglycemia / Foot Ulcers / Retinopathies) Cholesterol / Lipidemia (Hypercholesterolemia / Hypertriglyceridemia) Glaucoma Gastric Esophogeal Reflux Disorder Constipation Pneumonia Influenza Pediatric / Adult Vaccinations Nocturia Site Study Resources: -Early Phase: -PK/PD Studies -Safety / Efficacy -SAD, MAD, MTD -Inpatient / Outpatient -Phase I-IV -FIH, Phase 0-IIa -PH Monitoring -CGMS Testing -24 hr. Telemetry -24 hr. PK/PD/Pharmacogenetics -Drug to Drug Testing Trial with Multiple Cocktails -Neuropsychiatry Testing -QTc Trials -TET and Intense ECG Trials -Bioavailability/Bioequivalence Trials		Postherpetic Neuralgia Type II Diabetes Iron Deficiency Anemia Chronic Pain Study Lower Back Pain Study Peanut Allergy Pre-Screening Questionnaire Major Depressive Disorder Nutraceutical Energy Major Depressive Disorder in Children and Adolescents Walking Pneumonia Hypercholesterolemia (High Cholesterol) Major Depression Disorder - Bipolar Opioid-Induced Constipation Hypertension (High Blood Pressure) Type II Diabetes & High Blood Pressure