Parexel
Mapping The Future Of Care

Each new medical product (medical instruments, drugs and procedures) requires a different way of running trials. However, medical manufacturers across the globe are struggling with trial subject recruitment due to complexities surrounding compliance, ethics and safety of the patients. A CRO specializing in the above mentioned marketing challenges, can provide good return on investment for services rendered when looking to launch a new product. Parexel is one such U.S. based CRO service provider that understands the factors that lead to a profitable outcome in the industry. The organization leverages a patient centric policy that makes the recruitment process more convenient for both the patients and the manufacturers of medical products. Parexel builds customized designs of clinical trial for each profile, which helps tackle problems faced across the many phases of manufacture and commercialization.

The company follows ICH clinical practice guidelines and conducts clinical trials under the strict vigilance of qualified doctors, nurses and health professionals. Parexel solutions range across entire clinical trial life cycle. “From diversity in our recruiting, clinical trial and among our board, we are committed to inclusion across every aspect of our global organization,” says Jamie Macdonald, CEO of Parexel.

Choosing the right partner during the early phase can be key to the product’s journey. Parexel provides a simplified and dedicated approach to the initial stages, overcoming the usual slow and tense process offered by other CRO service providers. The company has set up early phase clinics for trials in multiple locations across three continents. Their clinical trial regulatory services team will help facilitate seamless services no matter where the client operates across the globe.

Later, for Phase-I trials Parexel will integrate a team of regulators, pharmacologists and transitional medicine experts to investigate the dosages, side effects and other safety measures to facilitate the smooth transition of the product to the next phase. Parexel offers an experienced team that is focused on taking the product to the next phase of clinical trials and its latter success. During this phase of testing, the team will try to understand how the product is interacting with the body, recognizing if there are any side effects and then transition the product to the next phase of testing.

Parexel also utilizes strategies that combine clinical pharmacology modeling and simulation with Pharmacokinetics and Pharmacodynamics to deliver comprehensive results.

In Phase II and III, the company will build a profile specific strategy called the target product profile (TPP) where its team will develop a commercially adaptable profile that can be applied across the many markets of the medical products industry. The target product profile (TPP) team will implement a scientific and regulatory analysis specific to their product to address the issues of marketing, manufacturability, pricing and intellectual property protection. Further, Paraxel’s Risk-based quality management services (RBQM) provides one of a kind monitoring strategy developed to overcome clinical development data challenges by using strategies such as central monitoring, remote monitoring and traditional onsite monitoring in clinical trials. The team constantly assesses forthcoming risks in every stage so it can be controlled when encountered.

Finally, for the last stage of clinical trial, Paraxel will deploy a project management team with global and local understanding of the commercials, to present a tailor made solution for the product. The late phase specialists, comprise of an elite team of 1000+ consultants that will help integrate regulatory and marketing solutions to help clients chart the most efficient course through the global market and to evade the commercial hurdles.

The various teams and strategies provided by Parexel constantly assess the risks and deploys new strategies that can be adapted to each stage. When combined with the ethical, safety and efficiency factors, it makes Parexel one of the pioneers in the industry.