BEEASY CONSULTING SRLS

VIALE F. STROZZI, 30 - 50129 FIRENZE (ITALY) * VAT n.: IT07244890484 * REA REGISTRATION n.: FI–689983 * FULLY PAID COMPANY CAPITAL: € 5.000,00

f7dad71ac5866080104079e123d06b8799d53d5e

b5e0ab4be14e5ef7ee2a83badce4a2e03b18356f

STRATEGIC FORESIGHT,
RISK-INFORMED DECISIONS

COOKIE POLICY - PRIVACY POLICY - LEGAL POLICY (TERMS OF USE) - ACCESSIBILITY POLICY

“The best way to predict the future is to create it.”
Peter F. Drucker

THE BACKBONE OF
SUCCESSFUL CLINICAL STUDIES

Clinical studies are notoriously time-consuming, with new drug approvals averaging 6 - 7 years, according to the Tufts Center for the Study of Drug Development. Delays can be costly - up to 8 million USD per day - while also affecting patient safety, treatment accessibility, site operations, and regulatory processes. Every setback adds financial strain, drains resources, and prolongs patient access to critical therapies.

However, efficiency does not have to come at the cost of quality.

A strategic approach to clinical study planning is essential to overcoming these challenges. Proactive site selection, streamlined regulatory approvals, optimized patient recruitment strategies, and effective risk management can significantly accelerate timelines while ensuring compliance and scientific integrity. With careful coordination between stakeholders, leveraging innovative technologies, and employing data-driven insights, studies can achieve greater efficiency without compromising safety or reliability. Success lies in a well-planned, adaptable framework: one that minimizes delays, controls costs, and ultimately brings life-changing treatments to patients faster.

80cf388a16b38f0df6bbf9ebebe749d4d3a0896a

WHY STRATEGY MATTERS

The European clinical research landscape is evolving fast: adaptive trial designs, decentralised technologies, and new ICH E6(R3) expectations all demand sharper foresight from Sponsors. BeEasy’s Strategic Consulting service turns that complexity into competitive advantage. We align scientific goals, regulatory pathways, and commercial endpoints so your study design, timelines, and budgets point in the same strategic direction.

Our team embed a risk-proportionate approach from the first protocol outline. Drawing on the latest ICH E6(R3) guidelines - which calls for Sponsors to “identify factors critical to quality and manage risks to those factors” - we map critical-to-quality (CtQ) elements, stress-test operational plans, and right-size data-collection demands. The result is a leaner, fit-for-purpose study that meets the applicable requirements while avoiding unnecessary complexity.

IMPROVING OUTCOMES THROUGH
STRATEGIC RISK ANALYSIS & MANAGEMENT

Robust risk analysis is not a one-off exercise: it is a living process that drives measurable gains in speed, quality, and cost control.
Leveraging the risk-management cycle outlined in ICH guidelines (i.e. evaluate, control, communicate, and review), at BeEasy we:

Quantify probability-impact profiles for recruitment, data integrity, and supply-chain hazards.
Prioritise mitigation tactics (e.g., site-mix optimisation, adaptive monitoring algorithms) where they deliver the largest quality return.
Monitor predefined quality-tolerance limits in real time, enabling early course-corrections that protect participant safety and keep databases clean.

Sponsors that have adopted this strategic, risk-based model with BeEasy have seen up to 40% fewer protocol deviations and 25% faster database locks across Phase I–III research programs.

LET’S MAP YOUR STRATEGY TODAY.

Whether you need a single-study blueprint or a portfolio-wide governance model, BeEasy couples strategic vision with practical execution. Our cross-functional experts turn risk intelligence into clear decisions, ensuring every subsequent service—feasibility, start-up, monitoring, or distribution—runs on a foundation built for success. Ready to transform uncertainty into opportunity?