SampleIQ is the engine that drives smart sampling programs, automating processes to optimize inventory and reconciliation data collection and compliantly provide samples to HCPs. SampleIQ enables our team to dive deeper into your engagement.


The most complete CRM engineered for life sciences and equipped with omni-channel capabilities. CATS empowers you to manage all interactions with partners and customers, access markets, and grow your business for accelerated commercial success.


Translating complex data into relevant information requires experience and knowledge. Synergistix and Archi-Tech bring decades of hands-on experience in life science data.

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Our mission is to deliver commercial solutions for life sciences in sampling services, CRM, and data management and analytics backed by comprehensive operational support.

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Synergistix started as a consultancy in 1997 and quickly evolved to focus on salesforce automation in life sciences, incorporating compliant sampling services over time. For nearly three decades, we’ve enabled pharmaceutical and medical device manufacturers to build effective teams, lasting customer relationships, and sustainable business growth.


With 25+ years immersed in sampling, CRM, and data management and analytics, we have an impressive, ever-evolving reserve of industry knowledge to share with you. Keep a finger on the pulse with Synergistix.

Direct to Patient Sampling, What You Need to Consider Before Making the Leap

June 22, 2021 | Synergistix

As a direct result of COVID-19 , Pharmaceutical companies have considered the concept of  “direct-to-patient sampling” where patients can receive various types of medication samples at their residence. The following information provides an in-depth look at direct-to-patient sampling, program logistics and potential issues that pharmaceutical sample distribution may create.

FDA Guidance

The FDA has recently released a statement concerning the implementation of direct-to-patient sampling programs in American healthcare companies. In their statement, the FDA specified that they will not take action against manufacturers or authorized distributors who engage in practice sampling during the COVID-19 pandemic. However, the FDA has not made any changes to current legislation. The FDA will permit direct-to-patient pharmaceutical sampling during the Public Health Emergency COVID-19 Initiative, which is expected to last until the end of 2021. However, the FDA has specified that patients must be identified as the “designee” to accept clinical samples. All other aspects of the PDMA CFR 203.30 must also be met.

PDMA Sample Compliance
protective surgical masks isolated in white background

Compliance and Regulations

Direct-to-consumer sampling providers must be sure to consider HIPAA, Patient Health Information state rules and PDMA sample accountability regulations. Participating companies should double-check their own compliance guidelines with federal and local data protection laws as well as their manufacturing and supplying partners’. For example, partners need the appropriate licenses to ship medicine to a consumer. When dealing with issues of compliance, it is crucial to communicate expectations clearly to patients and partners. Make sure that everyone involved can safely handle patient data and receive sample drugs.

State Restrictions

Across the United States, there are currently very few opportunities to implement direct-to-patient sampling. Many states will not allow shipping samples to patients or consumers at their residences. In fact, a minimum of 57 percent of the United States is unreachable for direct-to-patient sampling, or is difficult to reach because of waiver requirements. With this in mind, most people will not be able to participate in the program if it is put into place at this time.

Direct to Patient Sampling

Optimizing Patient Experience

Direct-to-patient sampling is designed to maximize patient experience, both in terms of convenience and in terms of safety. However, it is important to make sure that direct-to-patient sampling makes sense practically and logistically for patients’ well-being. It’s imperative to incorporate communication channels that resolve consumer issues, whether they be related to delivery, returns or even to product use. Direct-to-patient sampling must be feasible for patients and companies alike, beyond a purely business-minded perspective.

Implementing Policy Changes

Adopting a long-term direct-to-patient sampling program will require extensive changes to current legislation. Policies should be modified to include information about standard procedures, investigations, patient communication and much more. Beyond policy change, making direct-to-patient sampling a widespread option for consumers would require training and education for patients and providers nationwide. States will need to decide whether their long-term medical offering will include direct-to-patient sampling by considering the risks and benefits involved.


  • Direct-to-patient sampling is temporarily permitted by the FDA during the Public Health Emergency COVID-19 Initiative
  • 57 percent of the United States doesn’t allow direct-to-patient sampling or requires a waiver for participants
  • Direct-to-patient sampling programs give rise to numerous liabilities, logistical questions and potential communication errors between patients and providers
  • Legislative/policy changes will be necessary to make direct-to-patient sampling a long-term option after the Public Health Emergency COVID-19 Initiative

For more information about direct-to-patient sampling, PDMA sample compliance, or anything else, contact Synergistix. Give us a call at (866) 732-8665 or fill out our quick contact form today.


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Our company has been a Synergistix client for nearly ten years, and we've had nothing short of a positive experience! The dedication of the organization to the client is next level. Synergistix's expertise and attention to detail are truly unmatched, and we look forward to our continued partnership.

- Taylor Kananen: Manager, Commercial Operations
Almirall, LLC

We've been a Synergistix customer for over ten years now. I'd highly recommend Synergistix for their incomparable level of commitment to top-notch customer service and dependability. Our partnership is backed by their strong track record in the life sciences arena and excellent CATS CRM ecosystem.

– David Rodrigues: Director, Sales Operations
Exeltis USA, Inc

We've partnered with Synergistix for over fifteen years. As we deliver our products to diabetes patients nationwide, we need simplified, aligned data. Synergistix supplies us with precise target groups and tools to generate analytics and reporting for our sales reps and leadership team. Synergistix has replaced the need for specialized IT and allows us to be more nimble in decision-making. Customer service is impeccable. Our relationship is one of family, hence the term “partners.”

– Michelle Wakeley: Senior Manager, Strategic Sales Effectiveness
Ascensia Diabetes Care

Regardless of our business challenges and opportunities, I've found that Synergistix has always been able to keep up with our high expectations. Whether looking to expand our sales footprint, build new features into our CRM system, or leverage our CRM to its full capabilities, I've always counted on Synergistix for their opinions and expert feedback. I truly value our partnership with Synergistix and thank them for their continued support and dedication.

– David Rodrigues: Director, Sales Operations
Exeltis USA, Inc