Strategic Planning & Design

Transforming Drug Development Through Data-Driven Design

When you’re investing millions of dollars in developing a new drug, you need greater confidence in your strategic plan. New opportunities to leverage data can be complex. How can you access the right data and see it in the right context? Even after spending considerable time and budget, success is anything but certain.

What if you had a partner to help you systematically think through your upfront planning and design strategy? What if you had access to the full spectrum of relevant data to explore every possibility – all on an accelerated timeline? What if an objective team of experts could help you predict outcomes and pathways to success? That partner is Quintiles.

The Data Driven DifferenceTM – The Power of Knowledge-Based Strategies Our unique approach to optimizing drug development strategy helps you balance time, cost and risk, with the ultimate goal of improving your probability of success. Traditionally, the early strategy process – whether for a compound, program or portfolio – requires analyzing disparate data to inform your protocol and trial planning. Without a disciplined, evidence-based approach, strategies are often built on personal biases or isolated data points.

Powered by our breakthrough technology, Quintiles Infosario® Design, we harness the power of data to drive more informed strategic decisions. Our highly collaborative, data-driven approach to drug development strategy gives you more visibility into the right data insights, the objective expertise to validate critical decisions – and the agility to move quickly. The result? Greater predictability of trial success.

Increase Your Predictability of Success

VISIBILITY to leverage data

insights

EXPERTISE to validate decisions

objectively

AGILITY to accelerate

timelines

GreaterPREDICTABILITY

of success

Transform Your Drug Development for Better Results

The result of integrating expertise, structured process and data-driven technology

World-class expertise to inform design Tap into the knowledge of Quintiles’ drug development and therapeutic professionals and trial delivery, regulatory and commercial experts – more than 1,600 MDs and PhDs. Our 30 years of experience cross therapeutic areas at the molecule, program and portfolio level – and we bring an unbiased yet knowledgeable perspective to reduce the gap between strategy and execution.

A collaborative, structured design process From the initial information audit to our intensive design strategy session, our systematic process brings together your experts with ours to define the challenges and opportunities, identify data sets, test assumptions, debate pros and cons, and validate trial design. Imagine your molecule team working with our strategists to explore scenarios and create multiple protocol strategies in just days.

Robust technology for dynamic scenario modelingTo empower agile decision-making, Infosario Design delivers sophisticated data visualizations. These dynamic scenarios allow you to see instantly how each variable can change your outcomes. Infosario Design integrates data from diverse sources, including:

> Public data – clinicaltrials.gov, PubMed

> “Big Data” – EMR/EHR vendors, claims databases, registries

> Investigator data – Quintiles’ global network of investigators, sponsor investigators, cost data, physician lists, prescribing patterns

> Historical data – Your archived information from previous trials (optional)

For Better Outcomes, Design with the End in Mind

Integrated Approach for Confidence in Trial Design

Create and validate multiple protocols

through scenario building

Perform what-if, data-driven analyses

in real-time

Forecast trial challenges with enrollment

curves, timelines and cost estimates

Support scientific and operational

trade-off decisions

Define optimal country/site profiles based on actual

geographic footprint

Digitally capture and centralize design

decisions, assumptions and data sources

Strategic Planning & Design helps you…

Join us for success in the New Health.We’re here for you. US Toll Free: 1 866 267 4479 Direct: +1 973 850 7571 Website: www.quintiles.com/planninganddesignEmail: clinical@quintiles.com

The Right Decisions to Move Your Product Forward

Working closely with your molecule team, we can help you make decisions to balance time, cost and risk for your product, your program and your portfolio:

Planning & Design

> Product Development Strategy – Overview of molecule opportunity (medical, scientific, commercial, costs) and initial development plans

> Early Data Review – Gap analysis to identify data needs critical to defining product development plan

> Clinical Trial Modeling and Simulation – Design scenarios, simulation and trade-off analyses

> Clinical Development Plan – Scientific and commercial rationale, plus regulatory considerations to support the plan

> Protocol Synopsis Development – Overview of key study design parameters and endpoints compatible with ICH and CDISC guidelines

> Full Protocol Development – Comprehensive clinical study protocol development in compliance with ICH guidelines

> Integrated Product Development Plan – Strategic plan covering all components of the drug development spectrum for a molecule

Portfolio Management

> Portfolio Assessment – Analysis of market landscape assessment (scientific, medical, business as well as commercial financial analysis)

> Product and Portfolio Strategy – Formulation of strategic approach for a clinical development plan at the portfolio or program level

> Product and Portfolio Implementation – Oversight during execution of clinical development plan

There’s no better driver for success than intelligent upfront planning. Ready to find out how Quintiles can help you optimize your strategy for your product, program or portfolio? Talk to us today.

Better Design Yields Better Execution

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