Tackling the Bottlenecks of Today for a Healthier Tomorrow: Accelerating Drug Development in Study Start-Up

The recent pandemic altered our lives, economies, and the pharmaceutical landscape. In what we now call the post-pandemic, the drive for rapid drug development has increased. We're preparing for unknown future health crises. The goal? To expedite the drug development cycle—this is not merely about efficiency or cost-saving, it's about delivering safe and effective life-preserving achievements to a global community in a timely manner. 

Steps can be taken to speed up clinical timelines as early as the study start up stage. Management of essential tasks such as regulatory approvals, IRB/EC approvals, budget and contract finalization, and amendment documentation is pivotal for ensuring timely initiation of the study. This phase also sets the stage for successful patient recruitment, directly impacting the study's overall feasibility, timeline, and quality.

Below are 5 instances in which a robust start-up tool can prevent bottle necks and help accelerate drug development for your trial.

1. Regulatory Packages

Collecting required documents and templates from sites in a timely manner has traditionally been a challenge.  The standard approach is to collect these documents via email and then manually upload them into a file share system. Additional follow up emails often need to be sent and document submissions tracked manually.

Site activation tools streamline this process, allowing users to save time by sending document and templates requests to multiple sites with the click of a button. Additionally, these tools can track document submissions and send automated reminders for any outstanding documentation. Our experts estimate that automation of these activities can reduce the time needed to prepare these document packages by up to 70%.

1. Collecting budgets and contracts

Budgets and contracts are often bottlenecks during the site activation process, and there can be multiple rounds of negotiations before their final approval.  A good study start-up tool provides the ability to track budgets and contracts statuses across sites and can automatically upload associated files. Advanced SSU tools can even enable real-time collaboration by acting as a single source of truth during negotiation.

1. Creating Health Agency Submission Packages

Health agency approvals are required for sites to be activated. However, most health agencies have their own unique requirements which dictate how these documents should be submitted.  Documents may even have to be collated from different external and internal sources, which can make the job difficult and time-consuming.

Site activation tools can ease this bottleneck by providing a robust submission package creation system that affords users complete control over package configuration. Such a system lets users arrange documents in a particular order, implement custom naming conventions, and download all documents in a package into a single folder with ease. The more advanced systems can even employ automations to aid in the preparation of these packages. A dedicated SSU tool with features catering specifically to submission packages can save users up to 50% of time to submission.

1. Tracking IRB/EC approvals for Sites

Tracking approvals from IRBs and ethics committees for site activation purposes can also get tricky. Sites are very rarely approved at the same time, so trying to track and reconcile them manually can be time consuming and leads to potential human errors.

A good site activation tool should provide dashboards to track and monitor the progress of approvals for sites by IRBs and ethics committees. This can help to alleviate the oversight of protocol management and approvals.

1. Managing Amendments

Protocol Amendments are an unavoidable component of clinical studies. These can be triggered by factors like adverse events or a lower than anticipated recruitment rate, etc. With each amendment, new essential documents need to be collected and aggregated with the initial documentation of site activation.

A good site activation tool should provide the ability to manage and track these amendments in an effective manner. This means amendment notifications are sent automatically, and sites can submit amendment documents by simply replying to the notification email. This allows sites to leverage a dedicated inbox for each study they are participating in.  The documents are then automatically indexed to the corresponding site folders for easy management. By automating amendment management with features like these, users can reduce the time spent doing administrative tasks by up to 50%.