International HealthCare (IHC) employs top researchers in the field of Pain Management (PM).

Our staff’s breadth of research experience in this therapeutic area encompasses the full range of planning and executing pain management trials. This includes pharmaceutical drug treatment – pediatrics and adults; assessment of interventional pain management techniques for the diagnosis and treatment of pain and related disorders; as well as medical devices used as adjuncts in the delivery of these medications.

Our experience in clinical evaluations range from single center methodology and rating scale proof of effectiveness studies to large scale multi-center, multi-country studies successfully completed as pivotal studies in FDA submissions for IDEs, NDAs and RxÞOTC Switches.

Our extensive investigator database and trial expertise can ensure inclusion of the most reliable and well-known clinicians to conduct your trials and ensure its successful completion on time and within budget.

We have expertise in managing these studies whether they are utilizing paper, electronic diary data collection and/or Electronic Data Capture of the CRFs and Diaries.

We have provided full CRO services in the study designs for both OTC and Rx medications covering a broad range of therapies including narcotics, biologics/tissues and medical devices.  Our clinical experience includes such OTC analgesic drugs as Tylenol® (and its family of products), Excedrin® (also its family of products), Motrin®, ASA, Aleve® as well as a number of topical preparations.

For a brief assimilation of our expertise in Pain Management, we have categorized below; Treatment Areas, Staffing, Clinical Phase of Development, Pain Assessments Used and Scope of Services Offered.

Assessment of Pain in the Following Treatment Areas:

IHC Pain Staffing:

• CRAs on staff with pain management experience
• Regional contract CRAs with pain management experience
• Senior Project Managers with pain management experience
• Full Data/Statistical group experience in analyzing pain studies

Phase – Indication, (Trial Size):

Phase I –          Bioequivalence of Narcotics, (30 Healthy Subjects)

Phase II –          Wound Care Anesthetic, (20 Post-Surgical Subjects)

Phase II/III –      Nasal Anesthesia, (50 Surgical Subjects)

Phase II/III –      Trauma, Wound Care (580 Subjects)

Phase IV –        Headache, (750 Subjects)

Phase IV –        Dental Pain, (100, 60, 20 Subjects)

IDE –                Micro fracture, (300 Surgical Subjects)

IDE –                Spinal Stenosis, (400, 50 Surgical Subjects)

510K –              Breast Reconstruction, (140, 90, 60 Subjects)

510K –              Ostomy Pain, (110 Surgical Subjects)

510K –              Wound Care Diabetic Ulcers, (100 Surgical Subjects)

510K –              Varicose Vein Pain Relief, (10 Subjects)

 

Over The Counter Studies – Indication, (Trial Size(s)):

OTC  – Wound Care Topical Analgesic, (380 scrapes & bruises)

OTC  – Strains and Sprains (650, 80, 80 Subjects)

OTC  – Headache, (1350, 270, 450, 60, 40 Subjects)

OTC  – Dental Pain, (400, 250, 100 Subjects)

OTC  – Fibromyalgia Micro fracture, (300 Subjects)

OTC  – Cold Discomfort / Pain (400, 220, 80 Subjects)

Pain/Efficacy Assessments Used:

• VAS Scales (including Surgeon and Subject Satisfaction)
• Oswestry Disability Index
• Zurich Claudication Questionnaire
• SF-12 Health Survey
• SF-36 Health Survey
• Goniometer for Knee ROM
• WOMAC orthopedic scores
• Rhinometer
• Gnathodynamometer
• FACES pain scale (Pediatrics)
• Semmes-Weinstein & other filaments
• Duplex Ultrasound
• Other Standard Likert Scales

 

Scope of Pain Expertise Services Offered:

• Project Management, including Protocol Design
• Data Management, including paper and EDC (CRF & Diary)
• Statistical Analysis, with pain management expertise
• Clinical Writing, Summary Reports and full Clinical Study Reports
• Medical Coding, using WHO and MedDRA
• Pharmacovigilance (partnered service)
• IVRS (partnered service)
• Drug Packaging and Supply (partnered service)

Opioids, Analgesics, & Anesthetics

With patient hesitancy and diversion issues associated with opioid trials, it is essential to put together a research team of top experienced investigators. Selecting the right investigators and research coordinators will ensure timely enrollment, proper DEA handling of the study medication and proper attention to the protocol and study endpoints. IHC can help identify the most experienced researchers both domestically and internationally.

Real-time and close monitoring of the study endpoints is essential to trial success. IHC uses trial managers and CRAs that understand the subtle subjectivities of pain research data.

Experienced and niche providers are essential to completing the full scope of services required to perform opioid and PM studies. IHC has access to the top providers for services such as: Rating Scale and Questionnaire Development, Call-Centers, Patient Recruitment, Prescription Card Services, Language Translation Services, as well as Institutional Review Boards experienced in reviewing PM and opioid studies.

 Pediatric Exclusivity

Under the incentive and guidance of the FDA, pediatric pain trials are becoming an essential phase of opioid and PM studies. The difficulty in enrolling pediatric patients is compounded by the complexity, risk and media attention focused around opioid therapy. Our staff at IHC understands the needs involved in executing these trials.

Enrollment and enrollment rates cannot be taken lightly. Timely completion of these trials requires significant investigator recruitment on both a domestic and international level. IHC can help identify the right investigators for these complex trials.

IHC also can help you contact the right experts for all aspects of pediatric trials, such as: Protocol Design, PK Facilities, and Health Outcomes.