Pharmaceutical and Biotechnology Companies

The most common and costly mistake small pharmaceutical and biotechnology companies make in drug development is to rush into costly phase 3 studies without adequately understanding their drug, its pharmacology, and the clinical condition they would like to target.  The result is a poorly designed clinical development plan that is highly unlikely to achieve the desired goal of an NDA approval.  In the process, many millions of dollars are wasted, and all too often the company is forced into nonexistence.  Parallax Clinical Research provides guidance with intelligent clinical development by offering the following services:

·        Evaluating potential pipeline products

Potential pipeline candidates are often chosen based on interactions with putative drug targets, “proof of principle” studies in tissue culture or animal models, and basic animal toxicology studies.  Despite success in these pre-clinical studies, most drugs fail when they come to the clinic.  This is often due to the failure of the developers to adequately consider the differences in the preclinical model and the clinical setting, and to adequately consider the complexity of the clinical target.  Parallax has extensive internal experience evaluating drug candidates, and assessing the strength of the molecule as a development candidate.  We also have a network of experts to turn to for authoritative reviews, and have a great deal of experience identifying the most appropriate experts when we need to look outside of our network.

·        Creating Clinical Development Plans

The principals at Parallax Clinical Research have experience designing numerous clinical development plans that are focused on efficiently and cost-effectively advancing the drug candidate from a discovery pipeline molecule through development to the stage of NDA submission.   The key to a successful clinical development plan is to remain focused on the most important clinical objectives while maintaining scientific rigor in defining the important pharmacological properties of the drug when administered to human beings.  To accomplish this it is critical to have a firm understanding of the clinical condition being targeted, and the variety of ways it might be impacted by the drug.  This is what we do best.

·        Designing (synopsis and protocol) and conducting proof of pharmacology and proof of principle studies

For many new compounds, it is useful at the outset of the clinical program to conduct small, and relatively inexpensive proof of pharmacology studies that ascertain whether the preclinical observations that support the efficacy of the drug are valid in human beings and in the intended clinical target in particular.  These small studies are not necessarily focused on proof of efficacy per se, but tend to be focused on determining whether the mechanism of action reported in preclinical studies applies in a similar manner when the drug is administered to humans.   Once the pharmacology is established, it is then important to validate the concept in relatively modest but carefully designed phase 2 proof of principle studies that confirm the likely efficacy of the drug, and narrow the optimal dosing range and regimen.  Parallax Clinical Research is an industry leader in addressing these issues.

·        Designing (synopsis and protocol) and conducting all types of phase I – phase III clinical studies

In addition to assisting companies with the early stage determination of whether they have a viable drug candidate, Parallax staff has years of experience, designing and conducting  phase 1 through phase 3 clinical trials for a wide variety of indications.  We are up to date with the latest regulatory requirements, and keep the study designs grounded in a rigorous scientific approach.

·        Preparing Investigator Brochures, Clinical Study Reports and all types of Regulatory documentation

Parallax Clinical Research has wide ranging expertise in scientific writing, data management, and all operational aspects of clinical trial initiation, management and completion.  We have experience working with and supervising large and small CROs, and creating an effective study management team.

·        Medical Monitoring

Parallax Clinical Research has an excellent group of experienced clinicians who provide a sophisticated level of medical monitoring for all types of clinical studies. 


Venture Capital Groups

Venture capital is perhaps the most important force that drives the pharmaceutical and biotechnology industry.  Without it, only the largest and most successful pharmaceutical companies could even begin the arduous process of developing and marketing drugs, and many of the most innovative and exciting drug prospects would be lost.  Many venture capital firms lack the in-house expertise to adequately assess the scientific merits of the projects that cross their path seeking funding.  In some cases these firms rely on the diligence of other firms to take the lead in a round of funding, and join hoping that the lead funding agency did an adequate job.  Often poor choices are made to fund scientifically unsound projects, and worthy projects are left begging.  Realizing the critical importance of this process to drug development as a whole, Parallax Clinical Research has elected to venture in a new direction by sharing its expertise with venture capital firms.   Specifically, Parallax will offer assistance with the following:

·        Reviewing the underlying science and educating venture capital staff

Parallax knows science.  It is what excites us and gets us out of bed each morning.  Our scientific expertise and that of our network of experts extends to many different fields.  Where we do not have in-house or in-network expertise, we know how to find it.  To properly evaluate the value of a given prospect, it is important to have a fundamental understanding of the science that lies behind it.  We are able to evaluate the science behind any project, summarize it in a carefully worded report so that any layman may understand its fundamentals, and provide tutorials and seminars for analysts and other venture staff so that they can make sound investment choices.  We have the expertise to take complex scientific concepts and make them clear and painless regardless of your scientific background.

·        Evaluating the scientific validity of the proposed technology

Parallax Clinical Research’s experts are able to carefully evaluate the scientific merits of the proposed technology, and raise important questions that should be addressed in the due diligence process.  We can assess the practicality of the concept, its novelty, its clinical applicability and potential pitfalls with the concept.  This information will be provided in a detailed report followed by a presentation/discussion with the client.  We are able to take part in the due diligence process and provide whatever scientific expertise is needed.

·        Assessing the competitive and regulatory landscape for the proposed technology

An important aspect of any due diligence is to thoroughly evaluate the competition as well as any potential regulatory hurdles that might pose a challenge in the course of clinical development.  Parallax is able to research these issues thoroughly and provide an independent expert evaluation of the potential barriers to successful completion of the project.

·        Evaluating the competency of the company to accomplish the proposed objectives

One of the most important questions confronting the prospective investor, regardless of the soundness of the concept, is whether the Sponsor can execute the project successfully.  This is a difficult thing to know with any certainty, and no one can provide guarantees one way or the other.  However, our internal staff consists of individuals with decades of industry experience behind them.  They know what it takes to accomplish most difficult tasks, and know what to look for in evaluating a prospective company.  This type of expertise is very difficult to come by, and represents a particularly important commodity offered by Parallax to our clients.