Your data and documents deserve a safe landing.

At Blue Parachute, we've got your back! Our experienced team of pharmaceutical experts deliver you a 40,000-foot view of your project while identifying and diving into areas that might be at risk.
Image

Data and Document Search & Rescue Services

Learn how the Blue Parachute team can assist you in uncovering potential issues within your clinical trial data, monitoring activities, or trial master file documents that may pose risks to the success of your drug.

Data Review

From programming errors to numbers that just don't add up, there are a variety of data issues that can derail your clinical trial. If you're unsure of your data quality and want an independent review team to jump in, we're here to help!

Trial Master File Review

As the record of clinical research, the quality and completeness of your trial master file (TMF) are critically important to keep your drug's development transparent and auditable. How do your TMF Zones and Artifacts stack up? Let the Blue Parachute group find gaps or issues before an auditor.

Monitoring Oversight/SWAT Team

Is the quality of your CRO monitoring activity meeting your expectations? It's essential to provide oversight of your CRO's monitoring activities to ensure the collection of high-quality data. If you need a team of experienced CRAs to provide assurance or complete tasks such as pre-study evaluations, routine monitoring visits, or assist with preparation for interim analyses or database locks, we are ready to provide you that support!

If the Blue Parachute team uncovers additional areas of concern, we'll work with you, leveraging our extensive team experience and guide your project to a safe landing.
Testimonials

"Amy’s team displays an attention to detail, (without missing the forest for the trees) not often seen in consultant groups. The results we saw were on time, below budget and specifically what they said they would do.

We passed our FDA inspection with no findings."

Diane, Boston biotech company — Data + TMF Review

"Amy and I worked together on several massive global rescue TMF projects that lasted over a year, with over 600000 documents in scope of the TMF. Despite the shape of the TMF, Amy helped to develop a risk-based approach to bridge gaps between sponsor and CRO, to trace the drug, and to identify high-risk sites and their gaps."

 Carolyn, Director of Clinical Services & Document Management

"The work required strong technical acumen and adept interpersonal skills and Amy was amazing to work with - she is incredibly strong technically and shared that knowledge so the team understood the highest risk areas and could focus on addressing errors that mattered."

Linda, VP of Quality Assurance

    Let's Talk
    Outsourced your pivotal clinical trial and think your data quality or TMF might be in jeopardy? The Blue Parachute team will hear your pain points and propose ways we can help de-risk your program. Schedule a free consultation today!
    Book A Meeting

    Our Process

    We'll hand select suitable team members for each project. We pride ourselves on a collaborative and personable approach with our Clients.
    Step 1:
    Background Review & Understanding
    Step 2:
    Diving In
    Step 3:
    Deliver Results & Suggest Remediation

    An Alternative Approach to evaluating Data and Documents

    At Blue Parachute, we partner with sponsors and CROs to provide independent reviews of clinical trial data and monitoring activities and deep dives into trial master files. then identity remediation activities. We can provide monitoring oversight site visits, SWAT (i.e., rapid response) site visits, and evaluation of CRO’s CRA resources. We will uncover high risk issues and provide remediation suggestions or roll-up-our-sleeves and actually help remediate the issues.

    Why Our Team Loves It Here
    • We learn from one another.
    • We do meaningful work for our clients.
    • We feel appreciated by our Clients and our Leaders.
    • Our team meetings are organized and efficient.
    Why Our Clients Love Us
    • Our deep understanding of pharmaceutical industry challenges and curated teams.
    • Excellent communication and timely, high-quality deliverables.
    • Our expertise and guidance is worth every penny.

    Join Our Team

    We are always looking for detail-oriented individuals with industry experience to join us at Blue Parachute. If you have experience with Trial Master File remediation work or performing data reviews under tight timelines, we’re always looking to add people to our expanding team in order to serve more Clients. We are based in Ann Arbor, Michigan but will consider remote candidates if there is a good fit. We have full and part time work available for consultants and employees. Send us your CV, rate requirements, experience, and we will be in touch.
    Apply Now

    Book a Free Meeting with Our Team

    If you think your clinical trial might be in jeopardy, schedule a free, 45 minute consultation with us. Otherwise, you can Contact Us by email as well.
    Book A Meeting
    Contact Us