Manage FDA Clinical Trials with Contract Management Software

04/1/20

CobbleStone's leading contract management software can help with FDA clinical trial management. As Coronavirus (COVID-19) is now a global pandemic - with the United States presenting the most significant number of cases - I am reminded of current and past experiences implementing contract management software to help organizations with clinical trials and drug development tracking.  Organizations in the medical field, healthcare, pharmaceuticals, biopharmaceuticals, and other related industries need to effectively manage drug development contracts and obligations, clinical trials, manufacturing of medicine, and key opinion leaders globally.  CobbleStone’s leading enterprise contract lifecycle management software provides the solution to these challenges.

Although I must disclose that I am not an expert in medicine, clinical trials, or clinical law, it is worth mentioning that we at CobbleStone Software have over twenty years of contract management implementation experience - serving several pharmaceutical organizations along the way.  As such, we feel it is essential to help, in any way we can, with the development of the next medical solution for viruses like the strain we face in 2020.

Understanding FDA Guidelines

The United States FDA provides guidance in their Treatment Use of Investigation Drugs information sheet.  The information sheet states: “There are four requirements that must be met before a treatment IND (investigational new drug) can be issued:

  • the drug is intended to treat a serious or immediately life-threatening disease;
  • there is no satisfactory alternative treatment available;
  • the drug is already under investigation, or trials have been completed; and
  • the trial's sponsor is actively pursuing marketing approval.”

In addition to the information above, the FDA produces Selected FDA GCP/Clinical Trial Guidance for drugs and biologics.

Leverage Contract Management Software for Clinical Trials

An organization is typically required to undergo a clinical trial to get a new drug or a combination of older medicines approved. Here’s how CobbleStone’s cloud contract lifecycle management software, Contract Insight® helps organizations with clinical trials:

Adding Users: Contract Insight allows you to add users (such as doctors, nurses, scientists, administration, general counsel, paralegals, payers, caretakers, providers, and key opinion leaders) in a secure software system that helps you track key information for your clinical trials.

Third-Party Tracking: The system enables you to track vendors, suppliers, scientists, health facilities, legal staff, principal investigators, and other third-party personnel involved in your clinical trials, and you can interact with them via the Collaboration Gateway.  You can also track credentials, insurance certifications, and vendor compliance.

Creating Records: You can create records (including contract records, request records, sourcing records) and track and share data with key users.

Tracking Key Data Fields: Your team can track key data fields related to your clinical trial such as study type, study start date, estimated study completion date, treatment, description, enrollment, products, medical information, molecules, drug names, product branding, and formulas using configurable fields (that you as an administrator can easily add without the assistance of IT experts).

Learn how to read a study record. 

Budget Tracking: CobbleStone’s contract lifecycle management platform allows for detailed budget and finance tracking so you can oversee how you are funding the trial (whether you are leveraging internal funds, state funds, federal funds, grants, or investments).

Contract Lifecycle Management (CLM): Your team can track workflow tasks, approvals, key dates, and checklists (milestones) for each step of the contract lifecycle.  Calendar integration, email reminders, and workflow task escalation promote accountability within your organization.

Contract Writing: CobbleStone’s robust CLM suite helps with contract writing thanks to tools that allow you to draft agreements from templates as well as clause merging from your organization’s clause library.  Additionally, the approval process is streamlined and digitized with built-in electronic signatures.

Secure Repository: You can upload and manage important documents, agreements, insurance, and filings within a centralized repository.

Online Collaboration: Your team can track the parties involved in a trial and its corresponding contracts with the CobbleStone Collaboration Gateway, which allows your team to work online with key opinion leaders, scientists, vendors/suppliers, internal users, doctors/nurses, payers, providers, and other notable participants.

Clinical Trial Feedback: You can send surveys to obtain feedback on quality, treatment, and progress and track results.

Funding Compliance: Your team can track payments to ensure compliance with funding availability and payments to health care providers (HCPs).

Easily stay up-to-date on the latest pending (and available) clinical trials in the United States with a prefiltered list, or search to find a study for clinical trials.

I am amazed at how science and medicine have evolved.  If your organization is one of the inspiring leaders who have helped the fight against a variety of diseases - from salmonella to COVID-19 - we at CobbleStone Software want to thank you for the lifesaving magic that you perform on a global scale.

Get Started Managing Clinical Trials with Contract Insight

Healthcare and pharmaceutical administration, legal professionals, and clinical researchers face a myriad of complex challenges.  We know that this article cannot cover all aspects of clinical health care management.  However, with a flexible CLM software system, organizations can expect the rapid implementation of a solution that helps with the tracking of contracts, clinical trial information, tasks, legal documents, and other related legal information.

There is much more to discuss – so, if you are interested in attaining full governance over your clinical trials with our acclaimed source-to-contract software, please contact sales@cobblestonesoftware.com today!

Request a CobbleStone Software Demo

Mark Nastasi

Written by Mark Nastasi

Mark Nastasi is the Executive VP and founder of CobbleStone Software with over 20 years of professional experience in the industry.  He launched the first commercial contract software in 1995 named CMTS (Contract Management Tracking System). He has worked extensively with general counsel, paralegals, lawyers, and legal professionals to help manage contracts better.  You can reach Mark by email at mnastasi@cobblestonesoftware.com

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