Therapeutics Expertise:
Key to Study Success
Choosing a clinical research organization (CRO) with diverse therapeutic expertise is critical for the success of any outsourced clinical study in order to assess, manage and mitigate risk. As a full-service CRO providing Phase I-IV clinical trial support to the world's pharmaceutical, biotechnology and medical device companies, ProTrials Research has proven capabilities in all major therapeutic areas. Our highly skilled team offers the insights and expertise required to efficiently use resources, reduce waste and help speed new therapeutics to market.
Sponsors look for CROs with relevant experience in their indications; however, it's equally important to combine therapeutic expertise with the ability to tightly manage a study and deliver high quality data. provide one of the industry’s highest average years of experience, ProTrials delivers on both fronts with team members skilled at keeping clinical trials on track by avoiding delays and maintaining budgets.
Clinical Trial Experience
To successfully get a drug or device through the clinical development cycle, you need a trusted partner such as ProTrials. Since 1996 , ProTrials has delivered the proven leadership, experience and flexibility needed to complete more than 350 studies, some of which resulted in new blockbuster drugs entering the marketplace.
What makes ProTrials different? People. ProTrials employs the best, most qualified CRAs and Project Managers in the industry. Our CRAs have an average of 10 years industry experience and are dedicated to providing the highest quality data to our clients. Our Project Managers have over 14 years of industry experience and are passionate about leading your programs to a successful outcome. Most importantly, our employee retention rate is over 90 percent, so your project support is secure for the lifecycle of your trial.
We are a customer-centric organization with a very visible and involved senior leadership team. Our top priority is your satisfaction. At no additional cost to you, a dedicated senior-level Client Manager is assigned to each team to provide guidance throughout the project life cycle.
To successfully get a drug or device through the clinical development cycle, you need a trusted partner such as ProTrials. Since 1996 , ProTrials has delivered the proven leadership, experience and flexibility needed to complete more than 350 studies, some of which resulted in new blockbuster drugs entering the marketplace.
What makes ProTrials different? People. ProTrials employs the best, most qualified CRAs and Project Managers in the industry. Our CRAs have an average of 10 years industry experience and are dedicated to providing the highest quality data to our clients. Our Project Managers have over 14 years of industry experience and are passionate about leading your programs to a successful outcome. Most importantly, our employee retention rate is over 90 percent, so your project support is secure for the lifecycle of your trial.
We are a customer-centric organization with a very visible and involved senior leadership team. Our top priority is your satisfaction. At no additional cost to you, a dedicated senior-level Client Manager is assigned to each team to provide guidance throughout the project life cycle.
Our goal is to exceed your expectations - every time, no exceptions. We are dedicated to the success of your project, whether it is customary or multifaceted, and our experience spans a complete roster of study types, dose methodologies and regimens. We can assist you in developing a streamlined approach that ensures your study is completed on schedule and on budget. We then establish strong relationships with the Phase 1 clinical research units to ensure patient enrollment and protocol compliance objectives are met.
With a long history of successfully staging and managing clinical trials, ProTrials has the right resources to help you achieve virtually any exploratory early phase study goal, regardless of therapeutic area or type.
Highlights of Early
Phase Study Expertise:
Early Phase Study
Therapeutic Expertise:
| Absorption, metabolism and excretion |
Cardiovascular |
| Bioequivalence/Bioavailability |
CNS/neurology |
| Bridging studies |
Dermatology |
| Dose comparison |
Endocrinology |
| Dose escalation |
Immunology |
| Dose finding/ ranging |
Infectious disease |
| Drug-drug interaction |
Oncology |
| Food effect |
Ophthalmology |
| First in man |
Pulmonary/respiratory |
| Pharmacokinetic |
Rheumatology |
| Pharmacodynamic |
Vaccine |
| Proof of concept |
|
| Renal and hepatic impairment |
|
Choosing ProTrials for your Phase II - IV clinical trial helps protect your company's substantial R&D investment. Across the board, our team has one of the industry's highest average experience levels, meaning we thoroughly understand and can meet your protocol requirements. From randomized or double-blind to placebo-controlled studies - from simple to complex trials - our experts are focused on maintaining your project's schedule and budget.
Whether your company is a Fortune 500 pharmaceutical, biotechnology, medical device developer or even a small virtual pharmaceutical community, ProTrials knows and understands your business. We recognize your unique needs and adapt to meet them, all while maintaining our commitment to clinical operational excellence and quality.
Full Service Abilities:
ProTrials offers its services on a standalone basis, but the true advantage to working with us lies in our ability to support your project throughout every aspect of the trial :
| Regulatory Affairs |
Biostatistics |
| Project Management |
Medical Writing |
| Clinical Monitoring |
Clinical Quality Assurance |
| Clinical Data Management |
|
Our experience covers a broad range of
therapeutic areas, such as:
| Cardiovascular |
Musculoskeletal |
| CNS/neurology |
Oncology |
| Dermatology |
Ophthalmology |
| Endocrinology |
Psychiatric |
| Gastroenterology |
Pulmonary/Respiratory |
| Hematology |
Rheumatology |
| Infectious disease |
Vaccine |
For medical device developers bringing new products to market, ProTrials offers experienced clinical operational professionals with the resources and global reach to meet this industry's unique challenges: intense competition, precise regulatory requirements and shortened product exclusivity and life cycles. Our support, customized to meet your needs in multiple therapeutic areas, guarantees maximum results.
Our highly experienced medical device professionals are innovative and results-focused. We dedicate resources to every project, making our medical device development team an extension of our client's staff. By leveraging technological tools, we create seamless communications integration via a customizable, secure, Web-based project management and file sharing interface.
Medical Device Trial Expertise:
| Arterial closure |
Orthopedic |
| Cardiovascular device |
Peripheral vein graft stent |
| Corneal cross-linking |
Respiratory |
| Intravitreal implant |
Tubal ligation |
| Spinal implant |
Vascular imaging |
| Orthodontic |
|
Analgesia
Specific fields of expertise include:
Aesthetics
Specific fields of expertise include:
Cardiovascular
ProTrials has successfully managed and monitored over 50 global cardiovascular clinical trials. Although we support cardiovascular programs in Phases I-IV, we have specialized experience in Phase III trials. Completed investigational trials to investigator sponsored trials to a large, 600-site study involving 5,500 patients.
Nearly 60 percent of ProTrials' research employees have cardiovascular experience.
Specific fields of expertise include:
- Angina
- Anticoagulants
- Cardiac surgery
- Congestive heart failure
- Electrophysiology
- Hypertension
- Interventional cardiology
- Myocardial perfusion imaging
- Peripheral vascular disease
- Pulmonary arterial hypertension
- Stroke
- Transplant
- Valvular disease
Central Nervous System (CNS)
Today, the burgeoning field of neuroscience has produced many compounds for the research pipeline to address continuing medical needs. ProTrials Research has extensive experience in this key therapeutic area and is focused on bringing these compounds through the clinical development process as quickly and efficiently as possible, while maximizing the value of the data and information produced.
During CNS studies, a myriad of challenging situations can occur. You need a team of clinical research professionals who understand the complexities and nuances of studying and treating patients suffering from these disorders. With its concentration of resources and staff focused on neuroscience research, ProTrials Research offers the depth of experience in CNS studies that only a therapeutically focused CRO can offer.
Specific fields of expertise include:
- Alzheimer's
- Bipolar disorder
- CNS imaging device
- Depression
- Epilepsy
- Herpetic neuralgia
- Huntington's disease
- Migraine
- Multiple Sclerosis
- Myoclonic epilepsy
- Nerve generation
- Opioid dependency
- Parkinson's disease
- Psychiatric
- Schizophrenia
- Spasticity
Dermatology
Specific fields of expertise include:
- Acne Vulgaris
- Atopic dermatitis
- Eczema
- Peripheral arterial disease
- Psoriasis
- Scleroderma
- Severe Seborrheic Dermatitis
- Viral/bacterial infections
Endocrinology
Specific fields of expertise include:
- Cushing's Syndrome
- Diabetes
- Gastroparesis
- Hormone replacement therapy
- Hyperlipidemia
- IGF-I deficiency
- Obesity
- Oral contraception
- Pediatric short stature
- Phenylketonuria (PKU)
- Renal Anemia
- Vaginal Atrophy in Post Menopausal Women
Gastroenterology
Specific fields of expertise include:
- Antiemetics
- Crohn's disease
- Diarrhea
- Gastroparesis
- Gastric disease
- Irritable bowel syndrome
- Ulcerative disease
Genitourinary System/STDs
Specific fields of expertise include:
- Bladder disease
- Chlamydia
- Condyloma
- Dialysis
- Gonorrhea
- Herpes Complex
- Male erectile dysfunction
- Prostate disease
- Renal disease
Hematology
Specific fields of expertise include:
- Anticoagulants
- Hemophilia
- Non-Hodgkin's Lymphoma
- Paroxysmal Nocturnal Hemoglobunuria
- Sickle Cell Anemia
Immunology
Diseases caused by bacteria, viruses, fungi and other parasites pose health and economic risks not just to individuals, but communities and nations. The steady emergence of increasingly virulent pathogens makes the need for more effective treatments more urgent than ever.
Sponsors choose ProTrials because they know their clinical trials will benefit from a clinical operations team with industry-leading knowledge and a deep understanding of the unique complexities of immunology studies.
Specific fields of expertise include:
- Allergic rhinitis
- Anthrax
- CMV
- Hepatitis B
- Hepatitis C
- HIV
- Influenza
- Meningitis
- Smallpox
Infectious Disease
The market for products treating infectious diseases is an increasingly competitive arena. In order to speed novel therapeutics to market, you need a CRO partner that recognizes the importance of rapid clinical development without comprising quality. ProTrials Research team members have extensive clinical experience and training in infectious disease studies involving antivirals, antibiotics and antifungal compounds.
In the last 15 years, ProTrials has successfully completed research studies of antimicrobial agents, immunosuppression agents and antiviral compounds, involving hundreds to thousands of both inpatient and outpatient subjects.
Specific fields of expertise include:
- Aspergillosis
- Bacterial infection
- Candidiasis
- CMV
- Fungal infections
- Hepatitis C
- Herpes zoster
- HIV
- Influenza prophylaxis
- Influenza treatment
- Meningitis
- Pneumonia
- Sepsis
- STDs
- Tinea Pedis
Medical Devices
Medical devices follow unique development processes. It is important to choose a CRO partner offering the expertise and insights needed to succeed in this rapidly evolving environment. More than 60 percent of ProTrials' global professionals have supported device trials on the leading edge of research, including:
- Arterial closure
- Biologic implants
- Cardiovascular device
- Corneal cross-linking
- Intravitreal implant
- Orthodontic
- Orthopedic
- Pain management
- Peripheral vein graft stent
- Radiographic imaging
- Respiratory
- Spinal implant
- Tubal ligation
- Vascular imaging
Oncology
Over 75 percent of ProTrials employees have oncology experience, making this therapeutic area one of our strongest in terms of expertise. With a successful track record covering a wide spectrum of cancer-related therapeutic indications, ProTrials Research provides high quality, full clinical research services from small dose finding and proof-of-concept studies to large, multi-national trials involving hundreds of patients.
ProTrials has significant experience monitoring oncology programs in Phase I through Phase III. Specific areas include:
- Advanced solid tumors
- Breast cancer
- CNS
- Colorectal cancer
- Dermatologic
- Gastrointestinal cancer
- Genitourinary
- GIST
- Head and neck
- Hematologic malignancies
- Kaposi's syndrome
- Leukemia
- Lung cancer
- Hematologic
- Hepatic cancer
- Multiple myeloma
- Myelodysplastic syndrome
- Myeloid
- Non-small cell lung cancer
- Ovarian cancer
- Pancreatic cancer
- Prostate cancer
- Small cell lung cancer
- Solid organ
Ophthalmology
ProTrials Research has a significant and recognized track record in supporting ophthalmology studies. We have provided clinical operational services to companies specialized in the investigation and development of drugs treating a range of ophthalmic conditions, such as age-related macular degeneration (AMD), cytomegalovirus (CMV), diabetic macular edema (DME), and dry-eye.
Through our unique operational model, ProTrials can effectively manage and complete groups of like-designed studies simultaneously, supporting rapid drug development. Over a six year period, ProTrials managed and monitored three parallel Phase III AMD studies for one sponsor. These studies involved site, vendor and central reading center management and auditing, and data management support. In this patient population, there was a tremendous amount of safety related review and field support to ensure the highest degree of compliance and adverse event reporting. All three studies supported a successful BLA submission and resulted in an important treatment option which dramatically improves the quality of life for AMD patients.
Specific fields of expertise include:
- Age-related macular degeneration (AMD)
- Blepharoconjunctivitis
- CMV retinitis
- Corneal cross-linking (Device)
- Diabetic macular edema (DME)
- Dry eye
- Ischemic optic neuropathy
- Pain related to cataract surgery
Pulmonary/Respiratory
Specific fields of expertise include:
- Asthma
- Bacterial pulmonary infections
- Chronic bacterial sinusitis
- COPD
- Cystic fibrosis
- Pneumonia
- Pulmonary function testing
- Pulmonary arterial hypertension
- Viral pulmonary infections
Rheumatology/Musculoskeletal
Specific fields of expertise include:
- Muscle spasm
- Musculoskeletal inflammation
- Osteoarthritis
- Osteomyelitis
- Osteoporosis
- Rheumatoid arthritis
Transplant
Specific fields of expertise include:
- Bone marrow
- Heart
- Liver
- Renal
- Solid organ
- Stem cell
