INC Research

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Inc Research.png
http://www.incresearch.com
INC Research Holdings, Inc
Type Public
Industry Pharmaceuticals
Founded 1998
Headquarters Raleigh, North Carolina
Key people Candace Kendle (Founder)
Jamie Macdonald (CEO)
James T. Ogle (Former CEO)
Dan Hartnett (CFO)
Mark Ouska (Enterprise Data Architect)
Number of employees 5000-10000
Related Certifications Certificate in Current Pharmacovigilance Regulatory Landscape
INC Research is a global full-service, therapeutically focused, clinical research organization (CRO), providing the full range of pharmacovigilance and safety services, biometrics, study start-up, biostatistics, project management, medical monitoring, medical writing, quality assurance and I to IV phase clinical development services for the world's pharmaceutical, biotech and medical device industries with a Trusted Process® delivery methodology. The company connects customers, investigative sites, and patients to accelerate the delivery of new medicines to market. INC Research is headquartered in Raleigh, NC, with running operations across six continents, in more than 110 countries, with approximately 6,600 employees worldwide. [1][2][3][4]

History

  • 1985 - University of Virginia key CNS programs were consolidated into the Brain Injury Research Program (BIRP).
  • 1991 - BIRP staff becomes part of the Neuroclinical Trials Center (NTC). From this year and all through 1998, NTC staff participated in more than 40 global CNS clinical trials involving 20,000 patients in North America, Europe, and Australasia.
  • 1996 - NTC became one of the first adopters of Oracle ClinicalT. Along with strategic partners in the industry, NTC played a major role in the co-development of Oracle's data clarification forms subsystem, as well as a CRF tracking module.
  • 1998 - NTC and Integrated Neuroscience Consortium (INC) combined to form INC Research. which developed an exclusive national network of private practice neurology, psychiatry and pain centers, all experienced in conducting CNS research studies. In addition to this core group, an extensive investigator database of CNS sites was developed.
  • 2001 - INC Research expands beyond CNS, adding oncology, pediatrics, and data divisions.
  • 2002 - INC Research expands into Europe with the acquisition of CRO Vujaklija - one of the first CROs in Central nad Eastern Europe. With the acquisition of its European counterpart, INC Research broadened its global reach to 32 countries and 17 offices worldwide. [5][6]
  • 2003 - Board member Jim Ogle has been promoted to CEO of INC Research.
  • 2004 - Further expansion in Europe with the opening of an office in Germany.
  • 2005 - Quickstart® is introduced, an innovative step ultimately leading to the development of Trusted Process®. [7]
  • 2005 - INC Research acquired NDDO Oncology BV, Amsterdam, the Netherlands, a global contract research organization in the field of anticancer drug development for strengthening a key therapeutic area and further expanding in Europe. [8][9]
  • 2005 - INC Research relocated its European headquarters and regional clinical office into a larger facility in Maidenhead, Berkshire, United Kingdom. [10]
  • 2006 - INC Research expands Phase IV capabilities including pharmacovigilance and drug safety through the acquisition of Pharmaceutical Resource Corporation (PRC) to carry out large-scale Phase IIIb and IV adult and pediatric trials. [11][12]
  • 2006 - INC Research expansion continues with the opening of the offices in the France, Russia, and Ukraine. By this time, INC Research had active operations in Bulgaria, Czech Republic, Hungary, Poland, Romania, Russia (Moscow), Serbia and Montenegro, Spain, the Netherlands, United Kingdom and also five offices in North America, including its global headquarters in Raleigh. [13][14]
  • 2006 - INC Research has selected SAS Drug Development and the SAS Enterprise Intelligence Platform for its clinical data analysis and integration to help its staff to focus on managing clinical trials while SAS provides installation and implementation support through its data center. [15]
  • 2006 - INC Research made a strategic partnership with the Medidata Solutions, a global provider of electronic clinical data capture (EDC), management, and reporting solutions for implementing Medidata Rave® through Medidata’s ASPire to Win™ Program, to support its customers across the U.S., Europe, Asia, South America and other locations worldwide. [16]
  • 2007 - INC Research has officially implemented its Trusted Process®, metrics-driven clinical trials methodology, in all of its clinical trial programs. The Trusted Process® is a series of phases that logically guide the customer through their trial with the repeatable and measurable methodology. [17]
  • 2007 - INC Research expanded its infectious disease capabilities through the acquisition of Advanced Biologics, full-service contract research organization (CRO). [18][19]
  • 2007 - INC Research extended its global operations into India through an equal joint venture relationship with Indian firm GVK Biosciences (INC GVK BIO). [20]
  • 2009 - INC Research expanded its global presence and therapeutic expertise through the acquisition of the therapeutic arm of the MDS Pharma by adding expertise in the vaccine, respiratory, cardiovascular, and endocrinology therapeutic areas. As a result of the acquisition, INC Research had nearly 2,000 employees with operations in 40 countries. [21][22]
  • 2010 - INC Research is recapitalized through the acquisition by Avista Capital Partners and Ontario Teacher's Pension Plan enabling pension plan, enabling investment in further growth. [23][24]
  • 2010 - INC Research added Quality Finish Camps phase to Trusted Process®. [25]
  • 2011 - In this year INC Research increased its size by more than double through the acquisition of the AVOS Life Sciences, Kendle, and Trident Clinical Research. With the acquisition of AVOS Life Sciences, INC Research strengthened its financial analysis and regulatory consulting services. AVOS Life Sciences became a new division of INC Research called AVOS Consulting. Kendle was acquired to make its Phase II to IV clinical assets comparable to those at Covance and with Trident Clinical Research acquisition, INC Reseach expanded its action in Australia, New Zealand, and India. [26][27][28][29]
  • 2011 - INC Research and Debiopharm Group™ (“Debiopharm”), a Swiss-based global biopharmaceutical group with a focus on drug development and companion diagnostics, made a strategic partnership, where Debiopharm will entrust INC Research with the management of a clinical study linked to an important project in Debiopharm’s pipeline. Both parties have furthermore agreed on a framework partnership pertaining to future clinical studies to be conducted by INC Research for Debiopharm. [30]
  • 2012 - INC Reseach receives "most consistent service quality rating" in ISR CRO quality Benchmarking report from Industry Standard Research, a nod to the consistency provided by the Trusted Process®. [31][32]
  • 2012 - INC Reseach INC Research added TransPerfect's Trial Interactive Technology as its Electronic Trial Master File (eTMF) solution, which is a secure, web-based platform that reduces the redundancies inherent in paper-based TMF management. [33]
  • 2013 - Jamie Macdonald toke over the role of CEO from James Ogle, who continued to serve as chairman after serving for nine years as INC's CEO and president. [34]
  • 2013 - INC Research was named "Top CRO to work with" in the CenterWatch Global Investigative Site Relationship Survey.
  • 2013 - INC Research became first global CRO to implement the Clinical Research Monitor Accreditation program, an internationally recognized standard for competence in clinical research monitoring offered through the International Academy of Clinical Research (IAoCR). The new Clinical Credentialing program which standardizes the training of clinical research associates (CRAs) established INC Research as the first accredited training center in the U.S. [35]
  • 2014 - INC Research continued expansion through the acquisition of MEK Consulting, which provided a wider presence in Middle East/Northern Africa (MENA). MEK Consulting was CRO focused on clinical monitoring with headquarters in Lebanon as well as operations in Greece, Turkey, and the MENA region, with previous ten years long cooperation with INC Research. After acquisition, MEK consulting started to operate and conduct business under name INC Research. [36]
  • 2014 - INC Research completed its IPO enabling innovative investments across the business to increase global reach and efficiencies.
  • 2015 - INC Research was named by SCRIP Awards as the "Best CRO" for its capacity "to keep up with the changing needs of their environment" and for being "an agent in driving positive change in the clinical development process."
  • 2015 - INC Research was ranked as "Top CRO to work with" among large global CROs in the CenterWatch Global Investigative Site Relationship Survey.
  • 2015 - INC Research was rated #1 CRO for having professional medical staff in clinical operations. [37]
  • 2015 - INC Research added clinical trial technology iCardiac Early Precision QT for evaluating the cardiac safety of new compounds in Phase I clinical development to reduce their customers' costs, and increase the accuracy, reliability and speed of cardiac safety testing in clinical research. [38]
  • 2015 - INC Research established strategic collaboration with DrugDev to drive increased efficiencies in clinical trials through enhanced access to and management of critical investigator and site data and became the first CRO to complete integration with and implementation of DrugDev’s SiteCloud platform. [39]
  • 2016 - INC Research has opened new offices in Japan as part of its long-term growth strategy in the country – the world’s second largest pharmaceutical market. [40]
  • 2016 - INC Research launched Catalyst program to strengthen collaborations with clinical research sites worldwide and in turn enhance patient focus and optimize study delivery to drive improved predictability of clinical trials and reduce development timelines for biopharmaceutical customers worldwide. The program aligns closely with INC’s Trusted Process® clinical development methodology. [41]
  • 2017 - INC Research and inVentiv Health, Inc., a leading, privately held global CRO and Contract Commercial Organization (“CCO”), announced the successful completion of their merger. The combination creates the only fully integrated biopharmaceutical solutions organization, including an end-to-end CRO and CCO. INC Research/inVentiv Health will continue to trade on the Nasdaq Global Select Market under the symbol “INCR.” The combined company will be known as INC Research/inVentiv Health on an interim basis until a relaunch under a new brand in 2018.

Services and therapeutic areas

Services [42]
Clinical Trial Management Data Services Strategic and Regulatory Services Post-Approval Services
  • Patient recruitment and retention
  • Project management
  • Clinical monitoring
  • Drug safety/ Pharmacovigilance
  • Medical affairs
  • Quality assurance
  • Regulatory and medical writing
  • Functional service
  • Clinical data management
  • Electronic data capture
  • Biostatistics
  • Strategic development services
  • Regulatory consulting and submissions
  • Clinical operations optimization
  • Pricing and reimbursement planning
  • Specialized support for patient registries
  • Safety surveillance studies, prospective observational studies
  • Health outcome research
  • Patient reported outcomes
  • Phase IV effectiveness trials
  • Health economics studies and retrospective chart reviews
Therapeutic expertise [43]
  • CNS
  • Oncology
  • General Medicine (e.g., infectious disease, respiratory disease, cardiovascular, endocrinology, immunology and inflammation, women’s health and pediatrics)
Cross Functional Solutions [44]
  • Biosimilars
  • Medical devices
  • Orphan & Rare Diseases
  • Pediatrics

Technology

Trusted Process®

The Trusted Process® is a metrics-driven trial management methodology developed by INC Research for managing every aspect of clinical studies which provides standardization of the trial operational aspects and enforces quality controls at every stage to reduce operational risk, variability and cycle times. It is a four-step approach which INC Research introduced gives results faster, while still guaranteeing data integrity and reducing operational risk and variability. [45][46]

Each step - PlanActivation®, QuickStart®, ProgramAccelerate® and QualityFinish® - is designed to maintain high standards throughout the process to support making informed decisions about study data and analysis. [47]

1. PlanActivation®

The first step in Trusted Process® clinical trials methodology begins with receipt of proposal request, from which INC Research therapeutic experts create the suitable study-delivery strategy of the trial protocol. [48]

2. QuickStart®

QuickStart® is the second step which proactively leads sponsors through their drug development programs reducing variability and increasing predictability in trial outcomes. [49]

3. ProgramAccelerate®

Through the ProgramAccelerate® step of Trusted Process®, INC Research recruits patients across global sites and provides proactive study management that helps continuous study development by overseeing the project activities and managing risks, along with the updates required by clients. [50][51]

4. QualityFinish®

The closing step is QualityFinish®, which begins with the first enrolled patient completing the clinical trial. Project management team is gathered again to evaluate project performance and to assure actionable data is used to develop the final deliverables, which is considered as the basis of the documentation necessary for filing with regulatory agencies. [52][53]

Worldwide locations

With multiple locations around the globe, INC Reaserch has developed global network of their regional offices and sites in over 40 countries and six continents. Here are listed countries with INC Research regional offices and sites: [54][55]

Locations [56]
North America

Canada, Mexico, California, North Carolina, Ohio, Pennsylvania and Texas

South America

Argentina, Brazil, Chile, Colombia and Peru

Central Europe

Bulgaria, Czech Republic, Hungary, Poland, Romania, Russia, Serbia and Ukraine

Southern Europe Greece and Turkey
Western Europe

Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, England and Scotland

Middle East Israel and Lebanon
Asia Pacific

Australia, New Zealand, China, India, Indonesia, Japan, Malaysia, Phillippines, South Korea, Taiwan and Thailand

Africa

Egypt and South Africa

Competition

The company’s competitors are primarily other full-service CROs and services provided by in-house R&D departments of biopharmaceutical companies, universities, and teaching hospitals. Its major competitors include ICON plc, inVentiv Health, Inc., Laboratory Corporation of America Holdings, PAREXEL International Corporation, Pharmaceutical Product Development LLC, PRA Health Sciences, and Quintiles.

Competitive factors include:

  • Experience within specific therapeutic areas;
  • The quality of staff and services;
  • The range of services provided;
  • The ability to recruit principal investigators and patients into studies expeditiously;
  • The ability to organize and manage large-scale, global clinical trials;
  • An international presence with strategically located facilities;
  • Medical database management capabilities;
  • The ability to deploy and integrate IT systems to improve the efficiency of contract research;
  • Experience with a particular customer;
  • The ability to form strategic partnerships;
  • Speed to completion;
  • Financial strength and stability;
  • Price; and overall value. [57][58]

Featured videos

Controversies

None

Top 5 Recent Tweets

DateAuthorComment
April 14, 2020antidote_me@INC_Research, for the first time, people can use Antidote’s search to answer a few questions about their health, t… https://t.co/dDFSlO4tO9

Top 5 Recent News Headlines

  1. April 06, 2016 - INC Research and CISCRP Announce Strategic Collaboration to Focus on Patient Awareness - INC Research announced a strategic collaboration with the Center for Information and Study on Clinical Research Participation (CISCRP), a non-profit organization dedicated to engaging the public and patients as partners in the clinical research process. Through this collaboration, INC and CISCRP will jointly develop and implement educational initiatives designed to bring greater awareness to the importance of clinical trial participation in advancing public health. [59]
  2. May 25, 2016 - INC Research Expands Presence in Japan with New Osaka Office - INC Research announced the relocation and expansion of its Osaka, Japan office in support of the Company’s long-term growth strategy both in Japan and across the Asia/Pacific region. [60]
  3. Feb. 22, 2016 - INC Research expands partnership with Society for Clinical Research Sites - INC Research announced the expansion of its partnership with the Society for Clinical Research Sites (SCRS), further demonstrating the Company’s continued commitment and leadership role in fostering strong site relationships globally. [61]
  4. February 17, 2016 - INC Research Holdings, Inc. (Nasdaq: INCR), launches Catalyst Program to Strengthen Collaboration With Clinical Research Sites, Enhance Delivery to Customers - INC Research announced the launch of its Catalyst program to strengthen collaborations with clinical research sites worldwide, in turn enhancing patient focus and optimizing study delivery to drive improved predictability of clinical trials and reduce development timelines for biopharmaceutical customers worldwide. [62]
  5. Oct. 07, 2015 - Medidata Names INC Research Winner of “Trial of the Future” Award for Operational Excellence - INC Research and Medidata, a leading global provider of cloud-based solutions for clinical research in life sciences announced that INC Research has been named the recipient of Medidata’s Trial of the Future Award in the Operational Excellence category. [63]


Top 5 Lifetime News Headlines

  1. March 6, 2014 - INC Research acquires MEK Consulting - INC Research has acquired MEK Consulting, a clinical monitoring-focused CRO based in Lebanon with operations in Greece, Turkey and the Middle East and North Africa (MENA) region. The move supports INC’s strategic business expansion in high-growth regions to deliver global trials, and positions the company as a drug development partner in MENA, which offers access to more than 200 million new patients. [64]
  2. April 18, 2007 - INC Research Continues Expansion with Acquisition of Advanced Biologics - INC Research announced the strategic acquisition of Advanced Biologics to strengthen its Infectious Disease practice. Advanced Biologics is a full-service contract research organization (CRO) specializing in full-service clinical development to the pharmaceutical and biotechnology industries worldwide. [65]
  3. July 13, 2011 - INC Research completes acquisition of Kendle International - INC Research, a therapeutically focused CRO privately held by Avista Capital Partners and Ontario Teachers’ Pension Plan, has completed the acquisition of Kendle International in an all-cash transaction with a total equity value of approximately $232 million or $15.25 per share. [66]
  4. July 01, 2009 - INC Research Completes Acquisition of Global Clinical Development Unit of MDS Pharma Services - INC Research today announced it has completed the acquisition of the Phase II-IV operations (Global Clinical Development) of MDS Pharma Services, a business unit of MDS Inc. [67]
  5. December 1, 2005 - INC Research Acquires NDDO Oncology; Leading Therapeutically Specialized Contract Research Organization Expands its Global Oncology Expertise with Acquisition of Top European Anticancer Drug Development Company - INC Research announced today that the company has acquired NDDO Oncology, BV, a highly respected and experienced global Contract Research Organization (CRO) known as a leader in the field of anticancer drug development. [68]

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