Playing at the end of the game brings extra pressure

Regulatory submissions in life science industries are the most critical milestones in a new product development process and the subsequent product lifecycle. A solid submission process can accelerate time to market, bring the benefit of new treatments to patients sooner, maximize research investments, and preserve patient life. But playing at the end of the game brings extra pressure.

Many different tasks

Regulatory affairs staff have to deal with a variety of regulatory authority submission demands.

Many skills

You need skilled people with expertise in pre-clinical, clinical, CMC, labeling, production processes, change control, project management, etc.

A tight schedule

What are the capacity road blocks ahead? Will we lack CMC experts, clinical writers, regulatory project leaders? How should we flex between teams?

Correct execution

Above all, you need to ensure that the sequence of activities for a submission is correctly executed.

How Binocs solves this for you

Binocs is the easiest resource planning cloud solution for capacity and operational planning for regulatory affairs. It is at its best when it has to plan highly skilled resources that are active in a wide range of submissions.

Fostering a committed and high performing organization

One connected resource plan across the globe

Bye Excel. Shake hands with RIMS.

Connected horizons

A long-term forecast submission converts into a mid-term planned submission and is then confirmed for execution in the short term. All in one plan.

 

Connected plans

Each single resource plan requires alignment between regulatory teams. Make sure that alignment is valuable and move away from shaking out data errors.

 

Connected regulatory systems

RIMS (regulatory information management systems), change control tools, PPM (project portfolio management) systems. They’re good neighbors for Binocs.

Zero input. That’s our vision.

Focus on creating value, not on verifying data.

Teach the machine how you work

In Binocs you can describe your regulatory operating model. For example, what is the sequence of the regulatory activities for a technical variation and how does this vary by region, impact, etc.?

Binocs will capture submission demand from the RIMS and generate or update the work sequences dynamically. All automatically. Without user input.

 

Also, non-submission-related activities consume capacity

By means of a template, you can indicate on a consolidated level how much time goes into meetings, knowledge-sharing, training and other non-submission-related work. Binocs will automatically level this workload across weeks, months and quarters.

Immediate insights.

Run a scenario in less than 10 minutes.

Find the root causes at a glance

Binocs data analytics features will visualize why you will not be able to commit on a dispatch or submission date: unabsorbed submission peaks, insufficient qualified writers or just a massive overload in the publishing team?

 

And also find the solutions in the blink of an eye

It’s good to be aware of the issues. It’s even better if you can propose realistic solutions and action plans to your team and your management. Because scenarios are so easy and fast, you’ll run most of them instantly yourself. No need to wait for the expert.

Forward-looking KPIs

Whatever your past has been, you have an impeccable future.

A balanced set of KPIs to drive your performance

Binocs measures submission planning adherence as well as resource utilization and throughput. To ensure that the KPIs are reliable, Binocs will also consolidate submission process health checks.

 

Be able to bend future performance

Because Binocs uses advanced planning algorithms, it will tell you what the expected planning adherence and resource utilization KPIs are for the next weeks and months.

 

Unleash your performance dashboards

Binocs comes with configurable dashboards, accessible from anywhere. “Once again a submission out on time! High five!” Let your KPIs be motivators.

Need more convincing? No problem!
Request your demo and get access right away.

One connected plan

  • Connected planning horizons
  • Connected teams, across the globe
  • In sync with your RIMS and change management system

Zero input

  • Teach the machine how you work
  • Map also non-submission-related activities to get the full demand picture

Immediate insights

  • Find the root causes at a glance, but…
  • Also find the solutions in the blink of an eye

Forward-looking KPIs

  • A balanced set of KPIs to drive your performance
  • Unleash your performance dashboards

Blogs & cases from the field

Binocs is used for capacity and operational planning in regulatory affairsand uses a RIM system (Regulatory Information Management) as a source of demand. It already integrates with Liquent from PAREXEL. In Q3 2018 we plan to have an operational integration with VEEVA Vault RIM. Binocs provides a machine......

GSK Vaccines Global Regulatory Affairs (a team of 400+ people) presented their experiences with Binocs resource planning at the Making Pharmaceuticals conference that was held in Brussels on March 14th. Why did GSK GRA implement resource management? Why did GSK GRA choose for Binocs? And......

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