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IBM Watson Health takes on Healthcare Initiatives

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IBM has announced their new plans to further their involvement in healthcare, one a collaboration with the American Cancer Society and the second the creation of the IBM Health Corps. The ACS collaboration was formed with the goal of pairing IBM Watson Health’s artificial intelligence knowledge with patient-oriented healthcare, and the IBM Health Corp was formed with the goal of using AI to take on global health matters.

IBM created Watson Health a year ago in 2015, during which time the company has created partnerships and acquisitions in order to gain a steady supply of production revenues for AI applications.

American Cancer Society Collaboration

Together with the American Cancer Society, Watson Health is creating a virtual cancer health adviser geared specifically for patients.

“If you think about the challenges now with patients searching for information, they go to a book store or website to get it in a little bit of a reactive fashion. If it’s a recent diagnosis, they want to know what treatment to do,” Kyu Rhee, IBM VP and CHO said.

Currently, more than 14,000 pieces of information on over 17 cancer and wellness topics are already available on the American Cancer Society’s website at cancer.org. The adviser will utilize the pre-existing info and also information from the ACS National Cancer Information Center, which contains additional details about self-management, support groups, health activities and educational materials. The ACS and Watson Health expect to combine their efforts onto IBM’s current clinical support tool, Watson for Oncology, which will allow doctors to direct their patients to a more engaging and informational resource tool.

The virtual adviser is expected to launch in early 2017.

IBM Health Corps

Modeled after the Peace Corps, IBM Health Corps’ use is to apply Watson Health’s AI technology to face global health issues; primary care, health care worker populations, and access to food and safe water.

Two pilot efforts have already been in place – the first in Calderdale, U.K., and the second in Johannesburg, South Africa. Calderdale’s pilot sought the need to identify population health through unstructured data. Because over 65% of their population is overweight or obese, the pilot worked to set programs in order to increase physical activity, targeting youth and elderly residents in particular.

The Johannesburg pilot engaged an app from IBM, which encouraged hospitals to have a higher quality of staffing abilities in order to make up for the lack of staff.

A third pilot have been planned to take place for the community health center Unity Health Care in Washington, DC, to provide a manageable chronic disease program by uniting primary care and mental health care.

Servicing Patient Recruitment in Clinical Trials

The rise in technology in healthcare will provide ease-of-access in treatments for the future. With access to better programs and information, the public patient population will be able to have a hands-on approach to managing their diseases and healthcare related issues. Clinical trials will hopefully see a rise in patient participation as well, in order to parallel the active cancer-eliminating goal of both the healthcare industry and the general population. RESolutions, LLC is dedicated to patient recruitment so that you may enroll your trial on-time and on-budget. If you would like to learn more about our services or would like to speak with a representative directly, Contact Us today!

 

 

 

 

Patient Engagement and Tech on the Rise

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A recent CDW study confirmed a positive correlation between patient involvement and higher outcomes in the health care industry. 200 patients and 200 health care providers were surveyed in order to better comprehend views on patient engagement and how each groups’ needs and challenges differed. 57% of patients in the past 2 years have become more proactive in their health care.

In response, the health care providers are now going beyond their initial measures by utilizing more patient-engaging resources. 67% of these providers reported that they are working on methods in order to ease the process for patients to access their own personal health care records.

Technology providing a Portal to the Patient Population

The healthcare industry recently has seen a surge in user-friendly mobile/wearable technologies. In the group of 200 care providers alone, 28% said that they either provide or have plans to provide the data gathered from such medical technologies to their online patient platforms.

Both groups expressed their desire for an increase in patient engagement tools – the internet being the main source of accessing online healthcare information. 74% of the patients noted that with more access to healthcare info they would then be able to have a more active role in their personal care routine.

The Call to Action: only 35% of patients said that they have noticed an increase in patient engagement from their health providers, while 60% of providers said they place patient engagement as a top priority. In this case, the providers must respond to the patients. With regards to the patients’ self-knowledge about their medical information, the patients ranked communication with their provider at a high 50%, same as the rank they gave to an influential life event. That is, they value the opportunity to speak with a familiar medical professional as much as they do a personal event.

Servicing Patient Recruitment in Clinical Trials

Technology has given a wealth of knowledge to the general public, in all aspects. As the health care industry specifically works to make their own strides in released information, the public eagerly awaits. The public can also gain a deeper knowledge of what it is exactly they are volunteering for – and the act of providing knowledge is comforting in itself. Clinical trials are unarguably of great value in advancements in biotechnological and pharmaceutical fields, but without patients such advancements would not be possible. Continuing with the targeted patient-centric approach, your clinical trial should focus on the needs of the patient in your recruitment process, a feature that we provide. RESolutions, LLC is dedicated to patient recruitment so that you may enroll your trial on-time and on-budget. If you would like to learn more about our services or would like to speak with a representative directly, Contact Us today!

Enforcing Report Findings for Clinical Trial Results of Importance to Industry and Patients

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Yale University published their findings that 1/3rd of United States clinical trials results go unreported. 4347 trials between October 2007 and September 2010 were monitored throughout 51 medical centers. 2892 (66%) trials released their results, through journal publications or clinical trial registries, but the remaining 33% remained unaccounted for.

In 2000, the U.S. created ClinicalTrials.Gov, an online registry that mandated that every trial since 2007 with drugs subject to FDA regulation be submitted online. Only 26.8% have complied since then, with 12.6% resulting from just two years.

Key to Reporting: Enforcement

Publication rates ranged between 35-67.2% in individual institutions, while reporting to ClinicalTrials.Gov ranged between 4.1-55.4%. Those clinical trials that did have released results did not always do so completely: 21.9% of the entire study took more than 2+ years to publish to individual institutions, with 14.4% taking longer than 2+ years to publish results at ClinicalTrials.Gov.

Nihar Desai, a Yale assistant professor who worked on the study, said, “While there are statutory requirements to disseminate clinical-trial results, there aren’t any enforcement mechanisms. Investigators know that the requirements are requirements in name only. If instead, funders announced that previous performance on results dissemination would be incorporated into funding decisions, or journals would incorporate this into the adjudication of manuscripts, or leaders of academic institutions incorporated it into the promotions process, I suspect it would lead to a sense of urgency to ensure timely dissemination.”

Dr. Desai called for members of the International Committee of Medical Journal Editors to demand that trial investigators submit data with a 6 month process and for clinical trial patients themselves to have an active voice by asking for data as a part of the registration process.

Existing EMA Database

The European Medicines Agency (EMA) launched its own clinical trials results forum EudraCT, in January, where this information will be made public on the EU Clinical Trials Register. Trials with youths must be posted within 6 months, those with adults within 1 year. Each participating member state is responsible for penalizing non-compliant trial holders, a guideline with which the European pharmaceutical industry has so far been cooperative.

Servicing Patient Recruitment in Clinical Trials

James Cockerill, co-founder of AllTrials, said, “Missing results are a disservice to medical science, and a disservice to the thousands of clinical-trial participants who take part in trials.”

The more access all scientists and researchers have to each other’s published data, the more beneficial it is to biopharma development. The public can also gain a deeper knowledge of what it is exactly they are volunteering for – and the act of providing knowledge is comforting in itself. Clinical trials are unarguably of great value in advancements in biotechnological and pharmaceutical fields, but without patients such advancements would not be possible. Continuing with the targeted patient-centric approach, your clinical trial should focus on the needs of the patient in your recruitment process, a feature that we provide. RESolutions, LLC is dedicated to patient recruitment so that you may enroll your trial on-time and on-budget. If you would like to learn more about our services or would like to speak with a representative directly, Contact Us today!

 

 

Philips’ Focus on Patient Usability in Patient Monitoring Devices

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Royal Philips, the Amsterdam-based electronics and healthcare company, has unveiled a wearable wireless patient monitoring device for patients both in the hospital and patients at home. After announcing their intention to spin off their focus on lighting products to healthcare in 2014, Philips has placed its’ efforts into patient-centric device development, specifically both hospital and home-friendly devices.

Around the world about 40% of patient care units have Philips devices,” said Jeroen Tas, CEO of Healthcare Informatics Solutions and Services at Philips.

An area that has yet to be fully engaged, hospital and home health care has become one of the more pressing concerns of patients. The wants and needs of the patient has become dependent on mobile technology, and Philips has begun their attempt to take the lead in the mobile tech development.

H2: Philips Device: IntelliVue Guardian

IntelliVue Guardian, Philips’ new wireless patient monitoring system, contains a wireless biosensor and clinical support software & services. It was developed with the patient in mind, so that the patients may begin to use it while in the hospital and may continue to do so upon the return to their homes.

Carla Kriwet, CEO of Patient Care and Monitoring Solutions at Philips emphasized, “We envision a future where patients enabled by connected health technologies will recover faster with fewer complications and greater peace of mind in the hospital and subsequently at home.”

While the patients are in the hospital they are first monitored with the hospital-based Philips system, and then are fitted with a patch that continues to do so once they leave. Along with a single-lead simple ECG, the biosensor actively measures heart rate, respiratory rate, skin temperature and activity data throughout the day. The data is then wirelessly transmitted to the Philips IntelliVue Guardian Solution, which monitors for clinically significant data fluctuations. If the system is alerted of such changes, the patients’ assigned caregiver or physician is immediately alerted to the situation.

Along with the improvement in patient monitoring care, Philips expects that using the device will improve patient outcomes and reduce the overall patient cost for external monitoring.

H2: Patient-Centricity and Patient Recruitment in Clinical Trials

As technology develops and the general population becomes more dependent on the advancements, the medical and healthcare industry also seeks ways to keep up with the progress. Thus, an emphasis on patient-centric drug device application has been strongly demanded in the patient-care field. Clinical trials are unarguably of great value in advancements in biotechnological and pharmaceutical fields, but without patients such advancements would not be possible. Continuing with the targeted patient-centric approach, your clinical trial should focus on the needs of the patient in your recruitment process, a feature that we provide. RESolutions, LLC is dedicated to patient recruitment so that you may enroll your trial on-time and on-budget. If you would like to learn more about our services or would like to speak with a representative directly, Contact Us today!

 

 

Patient-Centricity in Drug Delivery Devices

OLYMPUS DIGITAL CAMERAAs medication self-administration becomes favored over hospital healthcare, drug delivery devices need to be provided to the patient with greater ease and efficacy. The ever-growing population has seen an increase in lifespans of those with chronic diseases, raising the demand for mobile treatment options catered to diverse patient groups.

In the earliest stage of drug development, the focus is on physiological and chemical aspects of the drug administration. The drug’s efficacy and safety requires as much consideration as its ability to improve the patient’s lifestyle and condition. Following the best method of administration is the challenge of addressing patient diversity. Because each patient differs in strength, size, dexterity, education, lifestyle, gender, culture, etc., his or her ability in utilizing the drug delivery device in their medical treatment must be considered.

The Need for Patient-Centric Approach in the Development of Drug Delivery Devices

According to Pharmaceutical Online, reports have indicated that patient non-adherence, instances when the patient does not maintain the recommended prescribed medicinal dosage, accounts for billions of lost revenue – $290 billion lost in the U.S. and almost double in the rest of the world. 4 billion prescriptions are assigned in the U.S. alone each year, with over half of them becoming void due to incorrect, or even lack of, administration. But in certain cases, rather than the failure of the patient to stick to their upkeep, the method of drug delivery itself is at fault.

With cases of Chronic Obstructive Pulmonary Disease (COPD), the ailment remains incurable, but treatment has proven to slow the disease progression while simultaneously providing a better quality of life. One of the treatments is applied through an inhaler device, which has many patient non-adherence issues. Occasionally, while the dosing schedule may be followed, the patient still may be using the inhaler improperly. A study showed that 89% of 316 patients using an inhaler made a mistake in their inhalation process, contributing to overall non-adherence. In instances such as this, the applicator is at fault, with the design not being patient-friendly in its application.

Two inhalers, the Diskus® inhaler by Advair and the Handihaler® by Spiriva were recently compared, with more patients preferring the Diskus due to the simpler usability in design. The hard evidence for such cases are bringing about positive changes in drug delivery device designs that focus on the results of human-centricity and patient-preference research.

How the Patient-Centric Approach Should Influence Patient Recruitment

The emphasis on patient-centric drug device application has been held in higher regard more so now than in the past. Clinical trials are unarguably of great value in advancements in biotechnological and pharmaceutical fields, but without patients such advancements would not be possible. Continuing with the targeted patient-centric approach, your clinical trial should focus on the needs of the patient in your recruitment process, a feature that we provide. RESolutions, LLC is dedicated to patient recruitment so that you may enroll your trial on-time and on-budget. If you would like to learn more about our services or would like to speak with a representative directly, Contact Us today!

Genentech’s Patient-Centric Approach to Clinical Trials

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As clinical trials are becoming a focus of health concerns in the upcoming push for medical advancements, certain negative aspects are unable to escape from the public eye. The lack of released trial information has been exposed by the press, as has the apparent lack of demographic diversity of recruited patients. In order to push for an effort to become more patient-friendly in their studies, Genentech has made patient-centricity a major point in their recruiting strategy.

Late last October, Genentech announced their new model for the patient-centric approach, with Joling Mew saying, “it is a model that puts the patient at the center of the trial, and its success relies on the patients partnering with us,” she says. “Almost everyone, at one time or another, has gone online to search for healthrelated information. Most everyone also considers their primary care physician to be a trusted partner for managing their health. Both of those factors are relevant to the model we are testing.”

Currently, the investigator-centric model consumes too much time, especially on identifying and qualifying the trial sites. Instead of focusing on the patient population, the sites are first identified, then later moving along with patient enrollment. Mew pointed out that the novel approach would be to locate the patient first and then locate an appropriate site, instead of the traditional site-first, then recruitment approach.

Technology’s Place in Patient-Centric Recruitment

As the presence of basic biosensors and mobile platforms increase, so does the reach of clinical trial sponsors. The strategy of locating the patient first and then the site would prove to be not as a smooth-flowing process as one would’ve hoped, so the next targeted approach builds off that theme.

The process begins with a principal investigator (PI), who then oversees the accountability and treatment decisions of the patient. Within that scope, patients are recruited through their local physicians’ and local networks’ digital platforms. Once they have expressed an interested and engaged with their physician, their local healthcare system goes through the approval process. This overall progression simplifies the ease in which the patient is enrolled, in opposition to the site-first approach.

The PIVOT Study

Genentech’s Patientcentric Innovative Vision hOme Testing (PIVOT) study is currently targeting patients with diabetic macular edema (DME) or age-related macular degeneration (AMD) using the mobile platform recruitment process. There are two arms being tested: one with the patient-centric recruitment through digital media like Facebook, Twitter or LinkedIn, the second with the investigator recruiting from his existing patient population based on eligibility with his staff then guiding through the qualification process.

Because the patient-doctor contact would be limited in a patient-centric mobile recruiting approach, Mew stated that the importance of relaying all and any sort of relevant information was made clearer in the first arm of the study. Genentech also accounted for the issue of physicians being willing to support patients outside of the investigational site, since the mobile approach would not have a standardized location for patients to check in. Ophthalmologists were surveyed and asked if they would be willing to provide information to such mobile patients, resulting with a vast majority supporting this method in patient recruitment.

 

Enroll Your Clinical Trial On-Time and Efficiently By Contacting RESolutions, LLC Today!

By targeting patient populations relevant to your clinical trial, RESolutions, LLC is dedicated to patient recruitment so that you may enroll your trial on-time and on-budget. If you would like to learn more about our services or would like to speak with a representative directly, Contact Us today!

FDA accepts Priority Review for Potential Renal Cell Carcinoma Treatment

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Eisai Inc., after submitting the New Drug Application for , announced that the FDA accepted the drug for Priority Review. Lenvatinib has the potential to treat patients with unresectable advanced or metastatic renal cell carcinoma (RCC).

The drug had previously been designated by the FDA as a Breakthrough Therapy drug, which is a status reserved for treatments that show a significant therapeutic improvement over already-existing therapies. The new Priority Review designation is applied to drugs that treat serious conditions and would have an impactful significance in safety or effectiveness.

Renal Cell Carcinoma

Renal cell carcinoma (RCC), also known as renal cell adenocarcinoma, occurs when malignant cells are found in the kidney’s tubules lining. In 2015, there were 61,560 new cases reported in the U.S., with 14,080 fatalities. It is the most common of kidney cancers, accounting for 90% of all kidney cancers in the U.S. The 5-year survival rate has a poor prognosis of 5-12%, with 40% of RCC patients having metastasized tumors after primary treatment. 16% of patients will already have metastasized tumors at the first diagnosis alone.

Regarding the Priority Review designation, Kenichi Nomoto, Ph.D., President of the Oncology Product Creation Unit at Eisai Product Creation Systems said, “With the FDA’s acceptance of this supplemental application, we are one step closer to potentially providing the first tyrosine kinase and mTOR inhibitor combination therapy to patients with unresectable advanced or metastatic renal cell carcinoma. We look forward to working with the FDA over the coming months as it considers this potential new option for patients with advanced RCC. ”

Lenvatinib as a Treatment for Renal Cell Carcinoma and Thyroid Cancer

Developed by Eisai, lenvatinib is a multiple receptor tyrosine kinase inhibitor and is currently sold under the name LENVIMA® to treat patients with locally recurrent or metastatic, progressive differentiated thyroid cancer (DTC). Eisai now aims to investigate lenvatinib’s usefulness in patients with unresectable advanced/metastatic renal cell carcinoma as well.

Lenvatinib inhibits other receptor tyrosine kinases that have been linked to pathogenic angiogenesis, tumor growth and cancer progression, including fibroblast growth factor (FGF) and the platelet-derived growth factor receptor alpha (PDGFRα).

For the specific purpose of treatment against various types of thyroid cancer, lenvantinib was formerly approved through the Orphan Drug Designation and under Priority Review designation by the FDA in February of 2015.

Enroll Your Clinical Trial On-Time and Efficiently By Contacting RESolutions, LLC Today!

Clinical trials are of great value in advancements in biotechnological and pharmaceutical fields. RESolutions, LLC is dedicated to patient recruitment so that you may enroll your trial on-time and on-budget. If you would like to learn more about our services or would like to speak with a representative directly, Contact Us today!

 

NIH Announces Genome Sequencing Program for Common and Rare Diseases

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Last week, the National Human Genome Research Institute (NHGRI), a division of the National Institutes of Health, launched the Centers for Common Disease Genomics (CCDG), in order to target the genomic bases of common diseases such as heart disease, diabetes, autism and stroke. NHGRI also announced the creation of the Centers for Mendelian Genomics (CMG), which will do the same genomic investigations with rare diseases, like cystic fibrosis and muscular dystrophy.

The research wing at NIH plans to give $240 million to the CCDG to identify the genetic factors in the common health issues, with another wing of NIH giving an additional $20 million.  CCDG plans to divide the total $260 million amongst Washington University, Baylor College of Medicine, the Broad Institute, and New York Genome Center, where the research teams will use another $40-80 million in additional NIH funding to map the genomes of tens of thousands of people with their population-scale sequencing techniques.

The Mission of the Centers for Common Diseases Genomics

Currently, the highly-targeting diseases are cardiovascular, metabolic and neuropsychiatric diseases. Inflammatory/autoimmune, bone/skeletal, and Alzheimer’s disease could all possibly be targeted as the program progresses. For each disease, the CCDG researchers will sequences over tens of thousands of genomes. By looking into genes that may trigger or inhibit development of diseases, CCDG may be able to use the genomic data comparing those with and those without the disease to pave way for improved treatment and prevention options.

Adama Felsenfeld, Ph.D., director of the NHGRI Genome Sequencing Program, said, “Building on existing research, they will continue to uncover new biological insights into the development of common disease. At the same time, these studies will reveal genomic variants that may increase the risk for – or in some cases, protect against – diseases, which eventually might be helpful for their clinical management.”

The 4-year NIH funding will go towards analyzing the existing sequencing, for as Richard Wilson, the principal investigator at Washington University said, “right now we can generate more data than we have the ability to analyze.” The Genome Sequencing Program Coordinating Center will use about $4 million on data analysis as well.

The Mission of the Centers for Mendelian Genomics   

Running in parallel to the common diseases genome sequencing drive, the CMG will account for analyzing the genetic makeup of rare diseases with the remaining $49 million. The National Heart, Lung, and Blood Institute (NHLBI) will contribute to both CCDG and CMG, while the National Eye Institute (NEI) will contribute to CMG alone.

The CMG program was started in 2011 with the goal of identifying the genomic causes of Mendelian diseases, rare disorders usually caused by single-gene mutations. Over the past four years, more than 20,000 human genomes have been sequenced and analyzed, and over 740 genes have been found that likely cause Mendelian diseases.

Lu Wang, Ph.D., the director of the CMG program noted, “Rare diseases provide an important window into the biology of both rare and common diseases.” By working alongside the CCDG, CMG researchers will continue to sequence the human genome to find the specific disease-causing genes.

 

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As research in the human genome mapping project grows, so does the potential to find treatments against both common and rare diseases. From that point, clinical trials are then exercised in order to test the safety and efficacy of hopefully life-saving treatments. Clinical trials are unarguably of great value in advancements in biotechnological and pharmaceutical fields. RESolutions, LLC is dedicated to patient recruitment so that you may enroll your trial on-time and on-budget. If you would like to learn more about our services or would like to speak with a representative directly, Contact Us today!

Clinton Proposes Tax to Fight Increasing Pharmaceutical Drug Prices

Hillary Clinton speaks in Washington

Reinvesting Funds from Advertising to Research

In response to the steep increase in drug prices, Presidential hopeful Hillary Clinton is proposing new rules for pharmaceutical drug companies requiring them to set aside a budget specifically on research and development, rather than marketing and advertising. Because marketing and advertising subsidies are corporate write-offs, companies are able to count those large sums as a tax-deductible business expense. Direct-to-consumer advertising increases prescription drug costs, exactly what Clinton is trying to avoid with her proposed plan.

(Martin Shkreli’s Turing Pharmaceuticals recently raised the price of Daraprim, a 60 year old drug, from $13.50 to $750/pill, over 4000% higher than the original cost. Turing Pharmaceuticals being the only FDA-approved manufacturer of Daraprim, Shkreli was able to control the price without legal opposition.)

“One of out every four people facing higher drug costs were also unable to afford medical bills or medications; one in five said they missed a payment on a major bill,” a Consumer Reports surveyed earlier this year.

The current corporate write-offs would be used instead to invest in paying for the R&D tax credit so that research on future drugs is emphasized. Successful marketing influences the consumer to spend money on the product. By increasing marketing funds, the pharmaceutical companies increase their drug prices in order to reach higher profits. If the budget on marketing was focused elsewhere, Clinton believes that drug companies would not be influenced by the market, thus ending the cycle of increased advertising and skyrocketing drug prices.

“Exit” Tax Strategy

This comes out weeks after Pfizer’s announcement that it would merge with Allergan, moving Pfizer’s New York headquarters to Allergan’s headquarters in Dublin, Ireland. Ireland’s lower corporate tax rate will cut Pfizer’s taxes from 25% to 18% – if applied in 2014, Pfizer would have saved nearly $1 billion of the $3.1 billion in US taxes.

 

“They’re doing it to save money on taxes. I want the Treasury Department to do everything it can to stop that kind of behavior and call it for what it is: gaming the tax system,” Clinton said about the $160 billion merger.

 

Overseas profits are not taxed until they are brought back into the US, but these taxes can be avoided by holding cash and investing abroad. Experts estimate that about 2 trillion dollars are hoarded abroad to reduce taxes. Corporate inversions allow for the overseas merger, an overall practice that lowers the US drug companies’ tax bills.

 

Currently, US companies can merge overseas if they transfer more than 20% of their shares to the foreign company they have acquired. Supporting the Obama administration’s proposal of raising the shares to more than 50% in order to discourage similar inversion deals, Clinton supports the change.

Rolling Out Proposals

Clinton’s campaign has been releasing her economic agenda, including increasing infrastructure spending by $275 billion and a higher focus on research and clean energy investments. The revenue gained by reinvesting drug funds into R&D and by employing the “exit” tax strategy is proposed to be spent on an increase in manufacturing jobs in the US.

Enroll Your Clinical Trial On-Time and Efficiently By Contacting RESolutions, LLC Today!

Any push on drug research and development would further serve both the drug industry and the general population. Clinical trials are unarguably of great value in advancements in biotechnological and pharmaceutical fields. RESolutions, LLC is dedicated to patient recruitment so that you may enroll your trial on-time and on-budget. If you would like to learn more about our services or would like to speak with a representative directly, Contact Us today!

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