Experience

V2 International Consultants, LLC is a multifaceted company that specializes in providing a range of high-quality oversight in operations, monitoring, management, SOP and Process improvements, etc., within the Pharmaceutical, Biotechnology, Medical Device industries, and Regulatory Agencies.

Our consultants have on average a range of 7 – 25 years of experience in oversight management: clinical development operations, monitoring, process improvements, etc.

What is Clinical Trial Medicine (CTM)?

Clinical trial medicine is defined as the science of designing, conducting and interpreting clinical trials. Clinical trials are concerned with finding and providing therapies for a group of patients with a disease. Patient safety is one of the most important priorities in clinical trials. The well being of patients and healthy volunteers always comes first in any clinical trial.

There are different stages of clinical research medicine:

All new medicines must undergo Phase 1 – 3 clinical trials before they are submitted to regulatory authorities for an approval to market. However, they must begin with preclinical testing to verify that a drug is sufficiently safe and effective to be tested in humans, followed by clinical (human) tests to verify the drug’s safety and efficacy for its proposed use.

PreClinical

The objective is to establish pharmacology and toxicology profiles, drug development formulation and secure authorization to test in humans.

Phase I:

Clinical testing of a new compound is used in humans for the first time and is usually limited to healthy volunteers. During this stage we establish pharmacokinetics, pharmacodynamics and dosing regimens. We also assess safety issues. Approximately 20 – 100 healthy volunteers participate.

Phase II:

During this stage proof of concept, testing of safety and efficacy (small scale) and evaluation of possible side effects are established. Approximately 100 – 500 patients with the disease participate.

Phase III:

Safety and efficacy (large scale) is confirmed during this stage. Adverse reactions from long-term use are monitored. The indication is also expanded. Approximately 1,000 – 5,000 patients with the disease participate.

Phase IV:

This stage is when the medicine has been approved by regulatory authorities and we continue to evaluate safety and generate data about how the drug affects specific groups of patients (e.g. the elderly, WOCBP). The number of patients involved will vary by size and make up (Campbell 79-80).

Medical Device Clinical Trials

Unlike drug trials, medical device clinical trials involve only patients with the condition which the device is designed to treat. The study of medical devices may not require clinical trials, and this depends on the risk stratification (or class) of the device. In the U.S., all Class III (and some Class II) devices require a clinical trial.

Clinical Trial Classification:

Pilot/Exploratory/Feasibility Study:

These studies are conducted in the early stages of device development. They tend to be small (10 – 45 patients with the condition) and are to determine preliminary safety and performance.

Pivotal:

These studies are conducted to demonstrate that the device is safe and effective for the specified use within the patient population under study. They tend to be larger studies with 100 – 300 patients with the condition.

Post-Approval/Post-Market Study:

These studies are conducted to collect long term data and are like the Phase IV of drug trials as the goal is to better understand the long-term effectiveness of the device and potential adverse events associated with the use of the device.

We have a vast range of consultants with experience in global Phase I – IV Drug clinical trials in various therapeutic areas, and stages of Device studies (Pilot – Post-approval); these can be tailored to meet your needs. Our consultants have an average range of 7 – 25 years of experience in clinical development operations.

Medical Device

Hands on experience in device trials:

Cardiovascular: Coronary Artery, Femoral Arteriotomy Closure – Stents, Vascular closure device
Orthopedics: Degenerative Knee Disease, Intracapsular Femoral Fractures Total Knee Arthroplasty (Rheumatoid arthritis, post-traumatic arthritis, Osteoarthritis, Degenerative arthritis, Failed Osteotomies, Porous Acetabular Cup, Triangular Fibrocartilage complex repair,
Rheumatology: Rheumatoid Arthritis, Psoriatic Arthritis – Injection e-Device