Spark Services

With all the outsourcing choices available to Sponsor’s today, why consider partnering with Spark? Here are just a few of the advantages we bring:

Let us ignite your program to the next level

With more than three decades of experience supporting biotechnology, pharmaceutical, and device companies, we understand the inherent challenges in operationalizing a clinical trial: timing, budget, quality, and resources just to name a few. That said, the last thing you need is a difficult outsourcing partner. You need a partner who makes your work life easier and contributes to the overall success of your program. You need an impetus, a driving force – a Spark.

It starts with an energized A-Team

A great team doesn’t happen by accident. On the contrary, it’s purposeful and intentional. That’s why we engage the industry’s best and brightest clinical research professionals to support our clients’ development programs. With Spark, you won’t get “who happens to be available,” as we hand-pick each professional based on the expertise required, the scope of work, and your desires. And, we encourage you to interact with potential team members to ensure the right fit culturally and professionally. Our service delivery crosses all functional areas of clinical operations including project management, clinical operations, pharmacovigilance, regulatory, data management, and biometrics. We can also bring you experts in other facets of your business including contract negotiators, training experts, board members, and other specialty positions. Not only can you customize but you should customize to fill gaps and add value. At Spark, our customization approach allows you to stay agile and innovative. Let’s jump-start your study your way.

Add specific backgrounds and expertise

You’ve always heard “it’s about the people.” It’s true in so many ways. Of course, having a team that connects with humor is nice, but we know clinical research professionals who enrich your studies and enhance its capabilities. We can bring experts to your table who are therapeutically aligned with your specific study. We are an extension of your team. When you’re successful, we’re successful.

Augmented contract staff

When you simply can’t hire the head count required for your program, engaging temporary staff is a cost-effective option. That’s true whether you need clinical resources to support your team for a week, six months or a year or more, or part or full-time. Spark’s large global network of clinical research professionals will ensure you receive the right talent each time.

Monitoring teams

There are times when all you need are regionally-based CRAs and/or a Lead to perform management oversight of the team while reporting directly to you. We identify and, together, select the appropriate and qualified team members. They’re ideally situated close to your study centers to save on travel time and expenses. Of course, each team member has the exacting therapeutic and functional experience to contribute to your program from day one.

Oversight monitoring

Now more than ever, Sponsors are opting to engage full service CROs to outsource their Clinical development programs. With the increase in outsourcing, regulatory authorities are cracking down on Sponsors for not providing the required oversight and governance for their outsourced projects. Should internal oversight resources be tight, Spark has a wealth of experience in supporting Sponsor’s with a variety of oversight services of their CRO’s to ensure:

Data integrity and patient safety: by performing field monitoring oversight visits including oversight plan creation and analysis of findings/trends
Compliance with industry standards
Contractual compliance: ensure Sponsor is being billed appropriately for services and deliverables invoiced
Targeted CRO selection and qualification including RFP preparation/proposal evaluations, scorecard creation and bid defense logistics and analysis
Site audit readiness visits to prepare sites for potential agency audits

AI oversight

With the infusion of Artificial Intelligence into clinical trials processes and data, an emerging need for human experts to provide quality review and oversight of the results, where it is clinical relevance of data or quality of a study report. Spark has the Clinical Research Professional that have the experience and expertise to ensure you achieve your goals.

Biometrics

Need lead data managers? Or a lead and support team? How about specialty programming such as biomarker, SDTM, or R programmers? Have a need for biostatistics support? Spark can provide you with just the right biometrics professionals from support roles to providing the entire team.

Medical writing

With a broad and highly experienced network of medical writers, Spark can provide that specific expertise to support your IND preparation, safety narrative writing, clinical study report generation, manuscripts and NDA section writing.

Ignite your clinical trials

Whether you choose to operationalize your clinical program and manage it internally, or outsource some of the functions, consider Spark. We’re proven experts in providing high quality, augmented clinical teams or single professionals who fully integrate with yours to create a powerful, budget friendly combination.

Perm Placement/Executive Search

With our unique network of candidates, let us find you candidates that will be a long term fit for your company and will be hired directly by you. We can do this stand alone or as a retained search.

Discovering your spark is about finding what fuels your passion and drives you forward. We help professionals uncover their spark and, with our expert team, ignite the flames of success in your clinical trials through innovative, tailored solutions.