We are committed to your success
A large part of the value that we add emerges from our ability to understand and integrate the 3 critical dimensions of clinical trial success:

• strategic
• scientific
• operational

First, we bring a strategic perspective to your clinical development planning.

Our experience can lead to your strategic success
Time and again our experience has shown us that, to be successful, every clinical trial must contribute to long-term corporate objectives. 

This is where we come in. 

Companies just like yours -- early-stage biotech, pharmaceutical, or drug delivery companies - engage us to help them in the year before an IND application filing in anticipation of "first-in-man" and "proof-of-principle" human testing. 

Our efforts begin by striving to envision - and, most importantly, integrate - the scientific, clinical, regulatory, and market factors that will transform a molecule into a corporate asset.

In order to achieve the first step in this strategic success, we work closely with your senior management team:

• Chief Executive Officer
• Chief Operating Officer, and/or
• Chief Scientific Officer

In short, we assist you in crafting a clinical development program that succeeds at the level of corporate business strategy.

Read a brief case history illustrating the Strategic Success dimension.

But a clinical protocol cannot succeed on a strategic level unless it also succeeds at the scientific level.

Our experience can lead to your scientific success
First trials can be "make-or-break" events for a young company like yours. These trials tend to be subjected to enormous internal and external scrutiny, time and cost pressures, and scientific scrutiny. BioStrategics Consulting Ltd evaluates critical path issues on the road to scientific success of your initial clinical protocols.

In such a setting, clinical protocols must be meticulously designed to address the threshold questions that need to be answered for internal decision-making, clinical relevance, and regulatory acceptance.

We have extensive experience working with expert clinicians (both domestic and international) and regulatory bodies (including the US FDA).  We'll help you ensure that your clinical protocols not only ask, but also are designed to clearly answer the threshold scientific questions.

Read a brief case history illustrating the Scientific Success dimension.

Ultimately, a sponsor must forge the third link in the success chain - by implementing the protocol and seeing it to completion.

Our experience can lead to your operational success
Like scientific success, operational success is a sine qua non for corporate strategic success.  BioStrategics Consulting Ltd has assisted numerous sponsors in the following ways:

• screening and selecting contract research organizations
• providing oversight and guidance for monitoring and clinical operations staff
• qualifying and educating clinical investigators
• providing medical monitoring services for Phase 1 and Phase 2 clinical trials.

We are particularly comfortable with the placement and management of first-in-man trials, and have assisted several sponsors (both US and European) in conducting normal volunteer clinical trials in the United Kingdom.

Read a brief case history illustrating the Operational Success dimension.


Begin to maximize your return on clinical development efforts
BioStrategics Consulting Ltd is committed to helping you realize the potential of your portfolio assets by maximizing your return on clinical development efforts. We bring a deep understanding of new product development; a proactive, problem-solving orientation; and a strategic perspective to every engagement.

To begin a dialogue about how we may be able to contribute to your company's strategic, scientific, and/or operational success, contact us today.