WHAT WE DO

THINK. ACT DO.TM -- These three words embody the BiggsB philosophy, which stems from 10+ years of battling fierce politics, fast deadlines and ever-changing compliance standards. It’s the approach we use for all of our projects and it drives our methods, strategies and communication. And it just plain makes good sense. A well-planned strategy needs to be developed before it can be executed.
And it doesn’t just work for the PMP. It’s the formula for success in any environment.

Agilecsv TM -- We call this “the game changer”. It was developed as the solution to an industry-wide issue. Why do computer systems validation (CSV) projects only deliver 25% on time? Why are they managed so poorly? Why do they cost so much?
Agilecsv TM combines the best of the agile iterative software development process with the traditional waterfall csv process and delivers a world-changing, game-changing, earth-shattering end result. Accurate. Better. Faster. Cheaper. It’s our little secret weapon. This is our approach to compliance, csv, qualification, production, facilities, GMP manufacturing, GLP production, studies, trials, CLIA, lab process, HIPAA, and health protection. We combine the main elements of informatics and compliance to focus on people, computerized system, processes, and data.

Contact us to find out more about what we do and how we do it.

A CASE STUDY

We don’t want to bore you with too many case studies that tell you how we overcame insurmountable odds. Blah, blah, blah. We’re tired of those too. Instead, here is one example of some stuff we think is pretty cool. If you want more details, we’ll be happy to oblige.

The One-Two Punch -- This is the one our team simply refers to as “That Project”. It’s the one that made us wake up in the middle of the night sweating. It’s the one that, at times, made us not sleep at all. It’s also the one that helped make us what we are today. The best in the business.

We use all our skills, but these were what allowed us to be successfull:

The First Hit: "Global Compliance Management"
We were intially hired by a major international healthcare company to manage their global compliance from a site location in Northern California. Our challenge was to implement and support their compliance systems as they continued to grow. We were helping to create a large site location with a strong infrastructure. No sweat. We live for this kind of project. Large. Comprehesive. Challenging.
Our team succeeded in delivering:

Global compliance management for one of the biggest companies in the business.
Managing 32 projects over the course of five years.
Successfully delivering nine global, top-priority projects over the course of five years.
Integrating our team of twelve with existing and new employees as the site grew.
Creating a harmonious work environment for in-house employees and consultants.

The Second Hit: “Site Closure Under Extreme Pressure”
Everything was flowing smoothly until chaos struck. In our fifth year on-site, our client purchased another major healthcare company. However, nobody was aware of this until the local news stations aired it publicly. And that’s how company employee’s at our site found out. As you can imagine, it created a work environment with many fires to put out. On the best day, what we do is challenging. Now add uncertainty and upset employees worrying about job security. We braced ourselves for what was coming
The last-minute word from our client was to close the site for relocation. This was massive. We were required to finalize all projects, plan for closure, analyze resource risks, develop timelines and budgets, meet with executives, develop processes for closure, connect with our teams, fight political battles, and make it happen. We did it.
Our accomplishment included: