Jeff Parke

	The core tenets of blockchain technology-a decentralized and encrypted way of distributing, sharing, and storing information-seem appealing for health data. The excitement around using blockchain technology in health care is also growing. Proponents point to blockchain’s potential to liberate data from entrenched silos, empowering patients to 

. This is a shared source of truth and has the capability to transform the clinical research industry. And what drives this technology is the drive to revolutionize patient care.

	In addition to increased costs, today’s researchers face the challenges of accurately reproducing data, efficiently sharing data (including personal data), privacy concerns, and patient enrollment strategies. This is where this level of “disruptive innovation” steps in and drives this technology forward. The best part about blockchain is that data stored in a blockchain is essentially impossible to hack, infringe, or steal, because the ledger is not kept on a single repository, but is spread throughout multiple databases in replicate copies. The advent of companies connecting their devices to mobile apps and the cloud will rightly necessitate greater consideration and discussion of cyber security risks. With enormous amounts of clinical trial data being generated every day, and pressures from commercial and regulatory agencies to overcome big data hurdles, it’s becoming obvious that legacy data management systems are not powerful enough to process and retain the data extracted from all the current research studies, posing problems for patient privacy, as well as data integrity.

	A major win for using a blockchain the biopharma industry can be seen in how patient data is collected, stored and its accessibility. It is imperative for investigators to have the ability to locate individuals for studies. With current technologies, however, data is scattered across multiple proprietary systems that are often independent and incompatible with each other, making it extremely difficult to recruit individuals for trials.

	A blockchain could also streamline the communication between doctors and patients during the trial. This kind of AI has the tools to provide smart contracts that endorse transparency and traceability over clinical trial sequences and can provide financial incentives for a patient’s participation and sharing of their data. This kind of organizational transparency and inclusivity can empower patients and doctors and improve the delivery of care.

	Another benefit of utilizing this level of innovation would be the ability for patients to better connect with individuals who have similar conditions (e.g., in rare disease populations), which can enhance trial referral potential. We need to remember that patient engagement is a key driver for any research and so we need to ensure that patient’s can find information that is available and has real value.

	There are some daunting facts relating to patient engagement in today’s clinical trials that are of concern. According to writers at Beyond Standards, some of these concern include:

	· Less than 5% of adult cancer patients participate in oncology trials

	· Fewer than 1 in 20 Americans know where to find relevant information on trials

	· 80% of clinical trials fail to meet their enrollment timeline

	These circumstances are further exacerbated by significant challenges in patient recruitment and retention, where the cost has continued to rise, and is estimated to consume between 30%-35% of clinical trial budgets, especially at phases II and III. On a blockchain, a clinical trial researcher or investigator could search candidates based on specific genetic, therapeutic, demographic, and geographic criteria without even knowing the patient’s name. In effect, blockchain can transform the patient engagement model by empowering patients to manage their complete electronic health record and giving consent to be searched for trial participation.

	What is Needed to Employ This AI Ecosystem

	- Need to demystify what blockchain is and its real value. Show industry doubters that this is not just a big hammer looking for a nail. Its real value could create greater data security and transparent governance models

	- Help create mind maps for workflows and processes 

	- Plans to establish trust among the various actors in clinical research is also essential, in the form of clinical research contracts, consents, and agreements.

	Emerging technologies naturally come with the art of the unknown. They have not been fully tried and tested; however, they hold promise to bring measurable benefits to humanity. Regarding blockchain, many have argued that the technology works and it is ready to be used in a variety of applications. Some areas that still need to be reviewed before this form of disruptive technology takes hold are:

	· What is the patient’s incentive for collecting/managing their own health record?

	· How will e-consent function with blockchain and smart contracts? How will digital signatures be employed? 

	· How will blockchain comply with GDPR, FDA, and other regulatory agencies as it relates to patient privacy?

	This new-age artificial intelligence is going to break ground in the biopharma industry, but when is truly yet to be seen. The industry is looking for the companies that want to be the leader of the pack and make a move on this new machine learning. However, in the immediate future, a more realistic goal might be to address issues around data integrity, reproducibility, and regulation, like GDPR transparency. While leaders in the industry try to adopt blockchain within the clinical research ecosystem, the most immediate need is arguably for resources to help them identify its intrinsic value. This level of innovation can be a win-win-win for investigators, pharma companies, and patients. 

Articles

The core tenets of blockchain technology-a decentralized and encrypted way of distributing, sharing, and storing information-seem appealing for health data.

Blockchain Use in Research

					Given the rapid changes in the communication landscape brought about by participative Internet use and social media, it is important to develop a better understanding of these technologies and their impact on health communication. From 2005 to 2017 participation in social networking sites more than quadrupled. In the health communication community, there is a widespread assumption that recent advances in Internet technologies, particularly social media, have transformed the pattern of communication, including health-related communications.

				In today’s changing healthcare landscape, the use of social media has a direct implication for health communication programs, prompting efforts to identify new opportunities of using social media to impact patient care. Social media has played an integral role in improving lives of patient’s and healthcare companies are on the forefront of this technological breakthrough through several important ways. First, the Internet-based social networks increase social support and interconnectivity among individuals. Second, with the increase of user-generated content, information sharing is seen as more democratic and patient controlled, enabling users to exchange health-related information that they need and therefore making the information more patient/consumer-centered Third, in recent times, public health programs have demonstrated success in adapting social media as a communication platform for health promotion efforts such as smoking cessation, kidney disease education, and dietary interventions, increasing their reach through cyberspace. Social media, a great information equalizer, is radically transforming the way people communicate around the world. Until recently the predominant communication model was "one" authority to "many". Social media has changed the monologue to a dialogue, where anyone with internet access can be a content creator and communicator.

				With the rise of health-related information being shared over social media on a daily basis, it is vital that healthcare workers educate themselves on how to keep patient information confidential.
				The Healthcare Insurance Portability and Accountability Act (HIPAA) was enacted by Congress in 1996 with the intent of providing patients more control over their healthcare records. HIPPA encompasses a variety of key points including:

						ï·  Implementing industry-wide standards for information provided on electronic billing

					ï·  Providing health insurance to individuals that are changing or have lost their jobs

				In terms of protecting healthcare information, HIPPA sets guidelines that pertain to the protection and confidential handling of an individual’s health records. These guidelines have become somewhat of an issue in terms of social media. Healthcare professionals cannot directly address patients through these outlets as it violates the privacy and confidentiality regulations outlined by HIPPA. Other healthcare facilities are encouraged to implement strict policies and guidelines for what employees are allowed to post on social networking websites. Some ways to avoid HIPPA violations include:

					ï· Distribute clear social networking policies to employees

					ï·  Avoid any discussion of patients, even in general terms

					ï·  Speak generally about conditions and treatments

					ï·  Prominently post your policies and procedures on all social media platforms

				ï·  Do not practice medicine online by responding to patients offline

			There is a variety of ways that healthcare managers are utilizing social media to enhance their services and provide patients with accurate medical information. Here are the top ways professionals in the field are using social media:

			Social media is intended to provide individuals the ability to access information quickly and communicate with others. Healthcare organizations utilize these tools and websites to share information with consumers in a variety of ways such as sharing general information about flu shots and tips to avoid a cold. Sharing news regarding outbreaks or health hazards is an effective way for healthcare facilities to provide accurate information to patients. It is important to note that all patient specific information requires permission along with a signed release. Other forms of sharing information through social media include:

					ï·  Provide updates on new technologies

					ï·  Introduce new doctors in a practice on social networks

					ï·  Answer questions on various topics (e.g. how to reach doctors or hours of operation)

				ï·  Offer patients any updates that relate to the practice itself

			Another effective way that healthcare managers utilize social media is by spending time evaluating their competitors to get an insight into the services they offer and overall patient satisfaction. By taking a look into different practices and their social media involvement, professionals have the ability to mimic these methods to enhance their own. Some organizations will do better through social media; providers can determine whether or not they need to take more appropriate action to quickly respond to patient requests and improve customer service.

			To gather feedback and improve quality, social media interaction can provide doctors and physicians with immediate responses from individuals to help understand common reactions to medications, as well as overall consensus from patients on new techniques in the industry. Using this information that is readily available on social media allows for healthcare organizations to learn from patient reactions and adjust accordingly. By following feedback on these sites, healthcare professionals also have the opportunity to evaluate the possibility of additional services in the industry.

			Some healthcare organizations have begun to utilize social media channels as part of their training process. During presentations, trainees are encouraged to use certain hash tags on Twitter or join other groups to engage one another to make training processes more enjoyable and interactive.

		These training techniques provide trainees a central location to ask questions and quickly receive answers. Social media gives participants the power to provide presenters with immediate feedback on training sessions.

		Trainees are not the only people who benefit from this social media technique. Organizations can use training videos and pictures from training sessions to engage audiences and enhance their social media channels by marketing their facilities and exemplifying their innovating training processes.

		Although somewhat controversial, there has been an increase of doctors and surgeons providing updates from the operating room. Through Twitter and other social media outlets, healthcare professionals have the ability to deliver up–to-date information during procedures to fellow doctors, medical students or simply curious individuals. Some say these updates are a distraction in the operating room, while others argue that it is an innovation and provides educational value that should be embraced.

		** Keep that “Dancing Doctor” in mind when discussing the possibility of sharing any medical procedure via social media!

		As a marketing approach, organizations create a buzz on social media with these updates, creating excitement and enhancing public awareness of an individual organization to attract patients and medical personnel.

		In times of crisis, the use of social media has increased to provide minute-by-minute information to consumers. Through social media, hospitals and other organizations are able to deliver real-time updates on hospital capacity, operation status, and emergency room access. Having an active social media presence allows healthcare professionals to pass along information shared by organizations such as the Red Cross, and the Centers for Disease Control or communicate with news outlets.

		As social media continues to become a valuable asset to healthcare organizations and new methods of use are implemented, the industry requires administrators to set guidelines and procedures for effectively managing these channels. To provide the best customer service and accurate information while adhering to HIPAA regulations, organizations need individuals versed in the healthcare administration.

		According to the Pew Institute, the growing popularity of social media in health care can be attributed to two key factors:

		1. The wide spread use of social media tools
		2. The growing desire for patients, particularly those afflicted by chronic illness, to connect with each other

		Coupled with other online resources, social media now largely impacts the way people interact with information-including health-related content. And while most patients continue to prefer face-to-face interaction with their health care providers, online health resources, including social, are now an extremely important supplementary tool in their health journey.

				There is a wealth of healthcare information and communication technologies that transform how providers and patients think about access, and act upon, digitally supplied healthcare information. The transformation has an impact upon the clinical encounters, rendering the traditional face-to-face patient encounters as one of many options, and often not the preferred one. Social media facilitates instantaneous information sharing and patients seem to be way ahead of healthcare professionals when using digital technology to access health information. With the easily accessible Internet and the Internet of Things (IoT) now increasing connectivity in the USA and abroad, patients and Healthcare Providers (HCP) are more able than ever before to communicate in ways that will change how patients receive care now and in the future.

					It’s no longer a matter of IF...it’s all about the HOW...Physicians and hospitals are personally well acquainted with social media and the Internet as a professional resource. The rise of social media in the world has affected many different aspects of our lives. From the way we communicate with others to how we shop, dine, and travel, social media has impacted how efficient and informed we are. Its impact on the health care industry is evident as well. The internet allows people to research symptoms, nearby doctors, and medications and their effects. More and more people are sharing information about health care, including reviews about doctors, their experiences with illness and opinions on different therapies. People can also use social media to ask for advice and search for information on the go, which is an important benefit to many people in the workforce who may not have time to consult a physician face to face.

						Rimal RN, Lapinski MK. Why health communication is important in public health. Bull World Health Organ 2009; 87: 247- doi: 10.2471/BLT.08.056713 pmid: 19551226.

						WallI, Robinson L. Leftinthedark:theunmetneedforinformationinhumanitarianresponses[policy briefing no.2]. London: BBC World Service Trust; 2008.

						Internet world statistics: usage and population statistics [Internet site]. Available from: www.internetworldstats.com [accessed on 13 July 2009].

						Leithner, A.; Maurer-Ertl, W.; Glehr, M.; Friesenbichler, J.; Leithner, K.; Windhager, R. Wikipedia and osteosarcoma: A trustworthy patients’ information? J. Am. Med. Inform. Assoc. 2010, 17, 373–374.

						“Rising Use of Social and Mobile in Healthcare,” The Spark Report.com, Dec. 17 2012, http://thesparkreport.com/branding/infographic-social-mobile-healthcare

Given the rapid changes in the communication landscape brought about by participative Internet use and social media, it is important to develop a better understanding of these technologies and their impact on health communication.

Take two and Tweet me in the Morning: How Social Media is Reshaping Health Care

	For the past couple of years, patient centricity has been a major buzzword in pharma. And these companies need to make a concentrated effort to ensure its new approach was more than just lip service. Sometimes the term is “patient-focused” or “patient-centered.” But because it is being used in so many different areas, the term “patient centric” has become a broad, almost catch-all term. Does it mean longer doctor visits, personalized gene therapy, big data collection and analysis, interactive electronic health records, new clinical trial designs?
	
	It’s clear that pharmaceutical companies are working to embrace patient centricity and figure out where it fits into their organization. Many pharma companies have actually changed its structure, creating the role of Chief Patient Officer. Responsibilities of the CPO include elevating the perspective of the patient and finding better ways to incorporate the unique priorities and needs of patients and caregivers. So what can the biopharmaceutical industry draw from this spectrum of patient centricity concepts? What are the core principles?

 – Relationships are not built in a day; they require long-term contact and trust built over time. There is no time limit on patient centricity. Industries must deeply invest in health consumers, meet them where they are, provide the information they need for adherence and progress and ensure an exchange that feels authentic.

 – Research has shown that we learn from stories that our brains are actually hardwired to remember. To be truly patient-centric, we need to emphasize the experience of patients, individually and collectively, not just the numbers they represent.

 – This approach requires listening to patient’s needs and wants and solving the problems they present in the best ways possible for them.

	Where can we look for inspiration to apply these concepts? In the consumer space, we see great examples of patient centricity’s close cousin, consumer centricity. Working with the principles outlined above, innovators have created new markets, launched successful products and programs, built brand loyalty and increased consumer engagement, all based on what their consumers want and need. Anyone who has ever needed a cab but had no cash or desire to stand in the pouring rain trying to flag one down knows why Uber is growing at such an explosive rate.
	
	So integrating patient centricity is really about listening to the experiences of customers and internalizing them throughout the organization to create better products and services, better engagement and adherence, and relationships that last. We undertake these efforts to improve the lives of our customers and the health of our businesses. While pharma has progressed substantially in its efforts to become patient-centric over the past years, the industry hasn’t yet reached the tipping point – where it becomes a growth platform. Being patient-focused should not be limited to specific initiatives or programs for patients; it’s a way of thinking, believing and acting.
	
	When patient centricity is seen narrowly as a cost of doing business, it will not be prioritized, measured and cascaded throughout the organization. Patient-centric growth will require companies to take a significantly big leap, which involves holding employees responsible for delivering on patient outcomes. Pharma needs to get into the business of exceeding customer's expectations. While pharma is saving and improving lives, we still have not been empowering our people with this sense of purpose.
	
	While pharma is creating a patient-focused culture, a key ingredient is teaching their people how to find the sweet spot’ - the place where everyone wins; patients, HCPs, healthcare systems and their organizations. Unfortunately, most employees do not know how to find the sweet spot or are conflicted between what management is saying from a corporate philosophy perspective and what they are being measured on. The key challenge for leadership is to train people on how to achieve the right balance of value or hire people with a talent for it. Moving forward, pharma needs to gain back our trustworthiness by authentically being patient-focused in everything we do. While there is no single bullet to address patient centricity, there needs to be steps to help companies reach their goals.
	
	Conquering diseases requires pharma companies to first regain the trust of industry partners and redouble their efforts at building new and meaningful partnerships. All of this is points toward a future in which the focus is truly on patient centricity, empowering patients and improving their outcomes. The bottom line is to know that in order to customize patient services and solutions, deep insights must be developed. It is not just one survey, one session or one focus group. It’s an organizational commitment to gain patient insights over time and over a variety of different patient groups.
	
	

 Research Project Coordinator, Site Management and Therapeutic Delivery Unit, QuintilesIMS

It’s clear that pharma companies are working to embrace patient centricity and figure out where it best fits into their organizations. How this concept will be integrated into the structure of a company remains to be seen.

The Secret to True Patient Centricity

 Every day we are faced with a changing biopharma industry and it inevitably impacts how CROs and other service providers interact with investigative sites/patients, as well as sponsors. All of these can be considered customers and the expectations as customers can pose a major challenge. How satisfied (or dissatisfied) customers are is determined by these expectations and a service provider's performance in meeting them. 

Of course, customer satisfaction is influenced by a complex interplay of factors; it's hardly as simple as plugging numbers into a formula and calculating the result. Nevertheless, this calculation serves as a reminder that customers' level of satisfaction can be affected by changes in either their expectations or a company's overall performance. That means service providers must pay attention to both.

And that's where things can get tricky, because how a service provider perceives their performance may differ from how their customers perceive it. In fact, discrepancies between a service provider's perceptions and their customers would not be at all unusual; experience has shown that most service providers routinely encounter such discrepancies.   

If a service provider customer's satisfaction level is changing, find out if something has happened, either at the customer's end or at the service provider's, to affect their expectations or perceptions. Whether those changes in satisfaction level are skyward or in the direction of the bottomless pit, analyze what's happening. If satisfaction is rising, a service provider must make it a point to find out what they are doing right, so they can keep doing it; if satisfaction is slithering downward, figure out how to reverse the situation before it falls off the chart and eliminate the potential to lose business. Items a service provider should focus on "doing right" are meeting customer expectations, such as important milestones (i.e., site initiation visit (SIV) before anticipated date). 

Service providers must make sure they do not get so wrapped up in delivering services that they lose sight of customers' expectations and how well they think they are being met. Be conscientious in observing what's going on in a customers' environment and how that could affect their satisfaction level. And a caution from the "we can always dream" department: don't make the mistake of concluding that if customer expectations fall, customer satisfaction will rise toward infinity. Math works that way, but customers don't. 

Service providers should reach out to their customers to identify the key issues that meet customer expectations (Table 1)  

Table 1. Service providers should reach out to customers to identify the key issues. 

Most customers don't demand the impossible. In fact, what they want is exceedingly reasonable. And what's that? Well, switch for a moment from the service provider hat to the customer hat. When we are a customer, what matters to us? What matters when we are at the doctor's office, or participating in an oncology research study?  

We all know that when we are the customer most of us want the same things: We want to be treated with respect, and we want to be listened to. We don't want to be bounced around or ignored or treated unprofessionally. We want to be fully informed about the protocol if one is the doctor, and about the treatment and any risks, or benefits from participating in a research study if we are a patient.  

Now, switch back to the service provider hat and think about it: both the product and the process are important to customers. The product refers to the solution, system, response, resolution, deliverables or result. Whatever form the product takes, customers want it to work properly, to meet their needs, and to ensure that it is safe and effective.  

But excelling in the technical element alone may not keep customers coming back unless service providers also attend to the processes. In fact, for many customers, the process is more important than the product. The process concerns how customers feel they've been treated. This is the human element of service and it is exceedingly important in achieving a high level of customer satisfaction.  

Providing correct information may not be nearly as effective as correct information accompanied by empathy, friendliness, and respect. Focusing on the process is a way to invest in a relationship. Customers who appreciate the way they've been treated accept occasional delays and glitches without complaint. In other words, an emphasis on the human element can give us some leeway in delivering the technical element of the processes. 

 Investigative sites deserve to know "when:"  

When will site "y" have an executed clinical trial agreement in place? 

When will site "z" receive payments for services performed and data submitted? 

If a service provider provides quality customer support, service standards provide a formal way to communicate this information.  

These service standards are expectations and managing statements used to minimize uncertainty about when some specified event will occur. The "when" may be a specific date or time, or more often, a time frame within which the event will take place. Consider these sample service standards:   

For acknowledging customers' voicemail messages: We will acknowledge messages within one business day of the call. For high priority calls, we will reply within one hour. 

For responding to service requests: We will provide written feedback on the action we will take within three days of receipt of a service request. 

For describing variations in service level: We will aim to resolve problems with products on the "A" (high priority) list within eight hours and products on the "B" (lower priority) list within one week of receiving a request for assistance.

A service provider's own time frames may differ. The issue is not the specific time frames, but whether they have established service standards and communicated them. When customers complain about poor service, it's often because of an absence of service standards that let them know what they can reasonably expect.  

The preceding three standards, like most service standards, are intended to handle routine or recurring situations. But what about situations in which we don't know what the time frame will be? For example, think about the last time: a malfunction occurred that had business impact; you didn't know what caused the problem, yet; customers immediately began demanding to know when service would be restored. This is when it is vital to keep our customers informed and updated as much as possible. 

Here's the lesson: When something goes awry between two parties, it's a common reaction for each to hold the other responsible. Each sees the other as having done something, or having failed to do something, that led to the unsatisfactory result. It's also not unusual for one party to find fault with the other, when the other doesn't even realize there's a problem. 

More often than not, the problem is due to a miscommunication, something that's easy to avoid. In particular, when you reach an apparent understanding with someone, you need to confirm that both parties have the same understanding. Clarifying what has been agreed to helps to ensure everyone is in sync. How can we all apply these ideas in our work? Never assume that the other party has the same understanding of what has been discussed. Ask questions. Check and double-check. State your understanding and ask if you have it right. Conclude with a restatement of what everyone has agreed upon. 

Regarding communication, we all want the simplest of things, such as more responsiveness, better phone manners, consistent follow-up, and most importantly, knowing whom to call with specific questions.  

Building intentional working relationships

A successful service provider will lead the industry by emphasizing a customer-centric business model along with tactics that enable work groups to improve output, such as clearly defining roles, streamlining internal and external processes, and improving communication among team members. This common sense approach is most effective when it strikes a healthy balance between the cold, hard effort needed to complete a task and the softer people skills necessary to forge a committed relationship in an engaging, quality-driven work environment. Research has demonstrated that customers are happier to provide repeat business and do better work when they intentionally form solid working relationships.

  When people focus solely on the task that needs to get done and they ignore the human element, much is lost and people are less productive. Elements of an "intentional" working relationship are listed in Table 2.  

 Table 2. The six steps to building strong internal relationships.  

For example, to improve the relationship between a service provider and their customer, service providers need to determine exactly what the customer needs. Most industry surveys report that sites want a "human element" as part of the relationship—they want to be appreciated and recognized for their hard work on increasingly complex protocols.

  They also prefer to work with a service provider that has productive, well-trained, and knowledgeable staff; use consistent protocols; set realistic patient enrollment goals; capture data proficiently; efficiently negotiate contracts, budgets, and a fair payment schedule; and maintain good communications with the site. This is a tall order, but putting processes in place to achieve at least some or all of these goals is a commitment a service provider must be willing to take.  

Service providers should reach out to their customers to identify the key issues that create stumbling blocks and stall performance (Table 3). 

Table 3. Key issues that sites have with CROs/sponsors. 

Here's how an "intentional" relationship might work in the CRO/sponsor/site world. Working together, service providers and customers set goals to double the enrollment rate and reduce errors in case report forms (CRFs). While the service provider can supply EDC technologies to reduce errors in CRFs and introduce portals to provide study-related information, service provider's staff must become the main contact for providing training, discussing enrollment strategies, and generally communicating the sponsor's agenda of continual improvement. Essentially what the service provider must become is an ambassador for the participating sites.  

Currently, conditions are ripe for the formation of these relationships. Facing a global operating environment of intense change characterized by capacity constraints, rising portfolio demands, cost containment, and depressed revenue and profitability, sponsor companies and CROs are looking to improve efficiency and performance, particularly from investigative sites. Yet, only a few organizations have announced or implemented plans and programs to support stronger site relationships.  

The service provider must view customer issues with urgency, making them a priority. The service provider must take the initiative to seek solutions with a positive attitude and stay in frequent contact with the customer. Also, a true partnership means the service provider must coach the customer in ways to improve. During this process, the service provider needs to show genuine interest and empathy for what the customer experiences during the trial and become an advocate for the customer. Finally, partnering entails making sure the customer understands the performance aspects and timeline expectations (Table 4). 

Table 4. Steps to implementing productive CRO/sponsor/site alliances. 

Strong working relationships among service providers and customers provide the backbone to start studies on time, raise recruitment rates and make sure both parties are on the same page. By opening up these lines of communication, the biopharma industry can expect to experience a positive shift in streamlined contractual and regulatory processes that will inevitably lead to the production of timely and quality study data as well as faster drug development. Essentially, when customers and service providers are working with the same goals in mind—to begin working on a study as quickly as possible—one can expect to see more projected timelines being met and more studies being initiated, the advancement of medicine, and greater patient care. 

A service provider's most precious asset is its customers' confidence in the service that is rendered. To secure a clear direction for its efforts, departmental heads must create a vision to ensure that they build a culture of service excellence and mutual respect to facilitate service to investigative sites, patients, and families.  

The strategic plan to achieve this vision includes dimensions focused on both people and the supporting systems of care. The ultimate goal is to create an ideal environment for service excellence. Such an environment must be innovative, proactive, accountable, and emphasize mutual respect and communication. The ability to provide great service to patients is what separates the best companies from the ones that lack a clear vision. 

The key strategic goals in pursuit of the vision are outlined in this article. The specific objectives and operational strategies must be designed and implemented by a successful CRO or biopharma company. 

The leading edge of a service provider's approach to excellence will be visible in the service they provide to their customers, be it an investigative site or the doctors and patients they work with on a daily basis. An outstanding healthcare experience for the investigative site and the patient population requires excellence from any service provider. Collectively both service providers as well as customers know that the most important driver of a successful study is the sponsor/CRO/site relationship. As a whole, any service provider must heavily focus on ensuring that tight deadlines are met and that impeccable customer service is provided to the customer. Customers must know that they are important and that the services provided to the community and medicine as a whole is appreciated. 

Goal 2: analyze and recommend service metrics and measurement processes.

 The key elements to any service provider's successes is a clearly articulated vision for service excellence, the passionate support of the organization, and a well-developed action plan to meet goals and metrics. For any service provider, to sustain its efforts in service excellence, there must be strong leadership support and principles of excellence should be evident in the organization's culture. Finally, service excellence must be integrated into the organization's strategic plan, operational plan, and measures of performance.  

 is Associate Site Start-Up Team Lead, Regulatory & Start-Up at Quintiles, 4820 Emperor Blvd., Durham, NC, e-mail: 

1. Lang, D. Paravincini, Y. Pigneur, E. Rivaz, " From Customer Relationship Management to Supplier Relationship Management, " HEC Lausanne University of Lausanne 2002 

2. B. Harper, "The Effectiveness of Sponsor/CRO-Site Performance Incentives", The Monitor, Fall 2005 

Building a culture of service excellence between sponsor/CROs and investigative sites.

Jeff Parke

Articles

Blockchain Use in Research

Take two and Tweet me in the Morning: How Social Media is Reshaping Health Care

The Secret to True Patient Centricity

Managing Customer Expectations