Inflamax Research Expands to the EU in Strategic Alliance with the Vienna Challenge Chamber

TORONTO, ON (PRWEB) JUNE 16, 2016

Inflamax Research Inc., a full service contract research organization (CRO) specializing in allergy, asthma, and ocular research utilizing environmental exposure chamber technology, with facilities in North America, announced today that is has entered into a strategic alliance with the Vienna Challenge Chamber or VCC, located in Austria. This strategic alliance will allow the expansion of multicenter EEC studies across the globe. Inflamax announced in 2015 an alliance in Japan with InCROM to bring their mobile EEC, mEEC™ system, to Japan. The mEEC™ is a state of the art facility designed to expose patients to controlled levels of airborne allergen, similar to those experienced in their daily lives, while reducing the variability of results, and increasing patient compliance compared to typical field trials.

“Our strategic alliance with the VCC team will further our goal to be able to effect multicenter EEC studies worldwide. We are excited to work with the renowned scientists, Drs. Petra and Réné Zieglmayer who have been thought leaders and pioneers in the development of the VCC system,” says Dr. Piyush Patel, CEO & Principle Scientist of Inflamax Research.

“We are pleased to be working together with Inflamax Research. We want to streamline our scientific efforts to develop the EEC standards and help our collaboration partners realize the full potential of their drug research. In our scientific approach we are aligned and excited to announce this alliance,” said Dr. Petra Zieglmayer.

About Inflamax Research
Inflamax Research Inc. is a full-service, Clinical Research Organization (CRO) with clinical research facilities in both Canada (Mississauga) and the USA (New Jersey). They specialize in allergy and asthma clinical research with over 25 years’ experience in the conduct of clinical trials and are a leader in Environmental Exposure Chamber technology. Inflamax is experienced in phase I clinical pharmacology through to late phase, global, and multi-centre clinical research services, as well as post marketing studies.

About Vienna Challenge Chamber – VCC
The Vienna Challenge Chamber is a scientific institution conducting basic and clinical research on inhalative allergies like rhinoconjunctivitis and asthma. The VCC research group is a pioneer in allergen exposure chamber technology: the first system worldwide was built in 1987 at the Medical University, currently the third generation of the system is in operation. Research activities are focussing on clinical as well as immunological monitoring of type 1 allergic reactions also in connection with phase 2 and 3 clinical evaluation of new compounds. Several hundred publications in peer reviewed journals document these research activities impressively.

Inflamax Research selected to join Ontario Premier Kathleen Wynne’s trade mission to Israel

TORONTO, ON (PRWEB) MAY 17, 2016

Inflamax Research Inc. is pleased to announce its participation in the upcoming trade mission to Israel organized as part of a provincial governmental initiative by Premier Wynne. Inflamax Research will aid in establishing Ontario as a leading knowledge economy partner and investment destination by forging new global connections with innovation leaders.

“As one of the Ontario businesses invited to be part of the delegation, we are eager to forge new global partnerships with other top innovators in the life sciences field,” announced Dr. Piyush Patel, CEO of Inflamax Research.

Israel is a significant research and development hub in the global development of medications and devices and therefore forms a significant market potential for Inflamax Research, a Contract Research Organization (CRO) which specializes in innovative drug and device development for the treatment of disease. During the mission, Inflamax Research will have many meetings with drug developers such as Teva Israel, a leader in global healthcare innovations.

While in Israel, Dr. Patel and Dr. Salapatek (Inflamax’s President & Chief Science Officer), will be participating in a signing ceremony with Dr. Alon Harris and Dr. Ra’anan Gefen from AdOm Tech, Israel. This Memorandum of Understanding (MOU) marks the commencement and contracting of the research program for development of AdOm Tech’s innovative Tear Film Imaging (TFI) device.

“Inflamax is excited to embark on this research together with our collaborators AdOm Tech. The TFI device bodes the potential to provide meaningful insights into the health of the human tear film,” said Dr. Salapatek.

Inflamax is a full-service, global Clinical Research Organization specializing in allergy, ocular, and respiratory diseases, led by world-renown, key-opinion leaders. Inflamax was recently selected as one of Canada’s 50 Best Managed Companies. Inflamax is experienced in the conduct of large single and multi-centre trials using their innovative fixed and mobile Environmental Exposure Chambers and direct instillation models from a study’s concept to protocol writing, site management, data management, and medical writing. Inflamax’s scientists and clinicians are well known to regulatory authorities and regularly participate in an advisory role.

Inflamax Research Inc. Announces the Successful Completion of Enrollment for the First Multi-center, Mobile Environmental Exposure Chamber (mEEC™) Study

Inflamax Research Inc., today announces the successful completion of patient enrollment in first US Phase II multi-center mEEC™ dose-ranging study with Grass MATAMPL immunotherapy for patients suffering from seasonal grass allergy (ClinicalTrials.gov NCT02582073) for Allergy Therapeutics

TORONTO, ON (PRWEB) MARCH 04, 2016

This is a landmark clinical study and is the first allergy immunotherapy study to utilize the mEEC™ in the United States. Inflamax’s unique and world leading technology was used to recruit and study patients in two separate locations in Neptune, New Jersey and Cincinnati, Ohio. The unique challenge in enrolling before the start of the tree season in the Northeast US was met with the deployment of Inflamax’s unique Online Central Recruiting Update Platform (OCRUP™). The data from this study will be instrumental in the launch of the Phase III program prior to end of 2016 utilizing Inflamax’s mEEC™ system in several locations within the United States. We also wish to thank the 20 investigator sites in Ohio, Kentucky, New Jersey, New York and Pennsylvania.

“Allergy trials rely on mother nature to produce consistent pollen concentrations to elicit adequate levels of symptoms in order to prove dose-response or efficacy. Unfortunately, climate change and variability in patient exposure in their everyday lives can lead to large variabilities and recruitment delays should the environment, weather, and other factors, not produce consistently. The novel mEEC™ technology enables study designs and endpoints to be infinitely more robust and allows for studying allergen-specific therapies, such as immunotherapy. The mEEC™ model is designed to provide consistent allergen exposure, over time, significantly reducing data variability and compliance compared to traditional field studies”, commented Dr. Anne Marie Salapatek, Chief Scientific Officer at Inflamax Research Inc.

Allergy Therapeutics® is a specialty pharmaceutical company focused upon the development of treatments for allergy. Allergy Therapeutics has an existing sales base of approximately £40 million per annum, an MHRA-approved manufacturing capability, as well as an established sales and marketing infrastructure in several major European markets. In addition, the Company has a number of novel compounds which have already undergone initial clinical evaluation and, once registered, could potentially revolutionize the treatment of allergy.

Inflamax Research is a global full-service, CRO specializing in allergy, respiratory, ocular and dermatology Phase I-IV research, led by world-known, key-opinion leaders. Inflamax has a strong scientific capability and publishes extensively in peer-reviewed journals. Inflamax’s Clinical Trial Management group has experience in conducting large multi-center trials in these, and other, therapeutic areas. Inflamax offers full-service including study design/concept development, medical writing, site management, monitoring, data management, statistics, and CSR development.

Inflamax Research Announces Positive Results of a Phase IIa Allergic Conjunctivitis Trial Testing a Novel Aldehyde-Trapping Molecule from Aldeyra Therapeutics

Positive results from a single-centre, double-masked, randomized, vehicle-controlled Phase IIa study in allergic conjunctivitis patients treated with NS2 ophthalmic solution from Aldeyra Therapeutics, Inc.

TORONTO, ON (PRWEB) MARCH 03, 2016

Inflamax Research Inc., a global full-service CRO specializing in inflammatory disease, announced positive results from a single-centre, double-masked, randomized, vehicle-controlled Phase IIa study in allergic conjunctivitis patients treated with NS2 ophthalmic solution from Aldeyra Therapeutics, Inc. (NASDAQ:ALDX). The study was conducted at Inflamax’s Toronto, Canada site and involved the use of the Conjunctival Allergen Provocation Test (CAPT) in patients with moderate to severe seasonal allergic conjunctivitis. The single-site study successfully randomized 100 subjects and used Inflamax’s innovative electronic diary system (ePDAT™) and electronic (paperless) data capture system (QDAQ™). The trial demonstrated statistically significance differences (p<0.05) between the NS2 treated group and the vehicle control group in ocular itching and tearing. NS2 was well-tolerated with no safety concerns. No serious adverse events were reported, and 98% of patients completed the trial.

“We are pleased to announce these positive and exciting results for Aldeyra’s NS2 ophthalmic solution and are impressed with this compound’s efficacy in allergic conjunctivitis,” said Dr. Holly Lorentz, Manager of Ocular Research at Inflamax Research.

Dr. Anne Marie Salapatek, President and Chief Scientific Officer at Inflamax Research, commented, “As a CRO with expertise in testing putative treatments for a variety of inflammatory diseases, Aldeyra’s unique aldehyde-trapping approach appears promising in ocular inflammatory diseases such as allergic conjunctivitis, and we look forward to continuing to work with Aldeyra on the clinical advancement of this novel aldehyde trap program.”

Allergic conjunctivitis is experienced by approximately 40% of the population and is thought to be mediated in part by pro-inflammatory aldehydes and leads to inflammation of various parts of the eye and eyelids, with corresponding symptoms of that often include itching, burning, tearing, sensitivity to light, redness, swelling, and mucus discharge.

Inflamax Research is a full-service, global CRO specializing in allergy, ocular and respiratory diseases, led by world-known, key-opinion leaders. Inflamax has a strong academic background and publishes extensively in peer-reviewed journals. Inflamax is experienced in the conduct of large single and multi-centre trials using their innovative fixed and mobile Environmental Exposure Chambers and direct instillation models from a study’s concept to protocol writing, site management, data management, and medical writing. Inflamax’s scientists and clinicians are well known to regulatory authorities and regularly participate in an advisory role.

Inflamax Research Announces Today the Commencement of a Phase IIa Allergic Conjunctivitis Trial

TORONTO, ONTARIO (PRWEB) NOVEMBER 23, 2015

Inflamax Research Inc., a full-service, global CRO, announced today that it has begun conduct of Aldeyra Therapeutics, Inc.’s (NASDAQ:ALDX) phase IIa study testing an ophthalmic solution of NS2, a novel aldehyde trap for inflammatory disease. This study will be conducted at Inflamax Research’s clinic in Toronto, Canada and involves the use of the Conjunctival Allergen Provocation Test (CAPT) as a direct allergen instillation model. This study will involve the enrollment of 100 subjects who suffer from seasonal allergic conjunctivitis and will employ the use of Inflamax’s innovative electronic diary system (ePDAT™) and electronic data capture system (QDAQ™).

“Inflamax is a world leading CRO that provides unique services utilizing controlled clinical models like the well-accepted Conjunctival Allergen Provocation Test (CAPT). We are pleased to be involved in testing Aldeyra’s exciting product, whose anti-inflammatory properties mechanistically hold a lot of promise for inflammatory diseases like allergic conjunctivitis” said Dr. Anne Marie Salapatek, President and CSO of Inflamax Research.

Allergic conjunctivitis is experienced by approximately 40% of the general population and is thought to be mediated in part by pro-inflammatory aldehydes and leads to inflammation of various parts of the eye and eyelids, with corresponding symptoms of that often include itching, burning, tearing, sensitivity to light, redness, swelling, and mucus discharge.

About Inflamax

Inflamax Research is a full-service, global CRO specializing in allergy, ocular and respiratory diseases, led by world-known, key-opinion leaders. Inflamax has a strong academic background and publishes extensively in peer-reviewed journals. Inflamax is experienced in the conduct of large single and multi-centre trials using their innovative fixed and mobile Environmental Exposure Chambers and direct instillation models from a study’s concept to protocol writing, site management, data management, and medical writing. Inflamax’s scientists and clinicians are well known to regulatory authorities and regularly participate in an advisory role.

Local Entrepreneur Completes Elite Ivey Program

Inflamax Research Inc. is pleased to announce today that Dr. Anne Marie Salapatek has completed QuantumShift, a unique leadership development program and network sponsored by Ivey, KPMG Enterprise, TD, and The Globe and Mail.

London, Ontario (PRWEB) May 14, 2015

Boosting entrepreneurial talent is critical for our country’s future. Successful CEOs and business leaders from across Canada have just finished an intensive program at the Ivey Business School in London, Ontario. These entrepreneurs are on the way to taking their companies to the next level.

Helping private businesses grow and improve their productivity is essential to building a more competitive Canada. Ivey Business School and KPMG Enterprise realize this and for the 12th year they invited a select group of entrepreneurs to participate in QuantumShift, a rigorous week-long program to give them the tools to push their businesses forward.

QuantumShift is designed to help Canadian business owners accelerate their companies. It’s for entrepreneurs who are past the start-up stage and who are ready to innovate. The program focuses on how to lead an enterprise through exponential growth; how to attract and retain the best employees; how to uncover obstacles that may be limiting growth; how to value a venture and use strategies for moving from business plan to financial proposition; and how to build a strong network of entrepreneurial peers to share best-practices.

With this graduating class, almost 500 successful entrepreneurs have completed the QuantumShift program, including Cameron Heaps, co-founder of Steam Whistle Brewery. Heaps is passionate about growing the craft brewing industry in Canada and says QuantumShift provided him with a unique opportunity to rethink his company’s operating structure.

“When you’re a young company in a high growth phase, often the structures aren’t keeping up. This was an opportunity to step back and start identifying where the cracks are and how to set up your business to sustain growth,” said Heaps.

“Like Cameron, I am very pleased to have joined the prestigious ranks of the Quantum Shift alumni and to have been given this opportunity to participate and learn at the Ivey Business School,” said Anne Marie.

Dr. Salapatek is Inflamax Research’s President and Chief Scientific Officer, who said of the program, “The Quantum Shift program has given us the time to reflect, and the latest in business practices and case study, which will help us to continue to move our businesses forward. Equally important, I had the opportunity to meet other successful entrepreneurs from across Canada. This will have lasting impact for me, as I now also have expanded my network of colleagues and friends that I can access for ongoing business support.”

Inflamax Research is a full-service Global Clinical Research Organization CRO that specializes in allergy, asthma and ocular research with extensive experience in design and conduct of clinical trials. Inflamax offers Natural Environmental Exposure Chamber models and has a unique, patented mobile EEC model which can be located anywhere worldwide for use in multicenter trials.

Inflamax Research to Present Data Demonstrating Validation of Environmental Exposure Chambers for Pivotal Allergy Research at the Paul-Ehrlich Institute in Germany

Dr. Anne Marie Salapatek will be discussing the validation of environmental exposure chambers (EECs) for use in pivotal clinical trials and how this clinical approach should be examined rationally for its utility in pivotal immunotherapy testing for allergies.

Toronto, ON (PRWEB) October 28, 2014

Inflamax Research Inc., a full-service CRO, announced today that their Chief Scientific Officer, Dr. Anne Marie Salapatek, has been invited to speak at the 14th International Paul-Ehrlich Institute Seminar on Allergen Products for Diagnosis and Therapy: Regulation and Science, held in Bad Nauheim, Germany from October 29th to November 1st, 2014. The international seminar has been an expert forum and medium for discussion for scientists and regulators for approximately 30 years. This year’s event will address industry standardization and regulatory issues related to diagnostic and therapeutic allergen products.

Dr. Salapatek will review the validation methods utilized for EEC clinical trials, including the selection of level of allergen exposure, and the spatial and temporal validation of EECs. Inflamax Research has been a leader in helping to develop the validation and operating standards for EECs. A review of the studies that demonstrate how EEC models provide accurate and precise research outcomes that are representative of those collected in the field will be the focus of her talk.

“The use of a well-controlled clinical model such as the allergy EEC model provides important insights into the actions of putative disease-modifying immunotherapies. This model makes possible the controlled yet naturalistic allergen challenge, which allows for real clinical assessment and screening of patients for immunotherapy trials, and allows for yearly follow-ups to examine whether immunotherapies can provide long standing benefit,” says Dr. Salapatek. “Regulators and researchers need to examine these data rationally. This will encourage rigorous testing of immunotherapies and their timely evaluation towards treatment of allergy sufferers.”

About Dr. Salapatek
Dr. Salapatek is an expert in the field of allergy research and designing studies for very specific regulatory requirements to prove safety and efficacy. She is an advocate for a model like the EEC in the conduction of small pilot-sized and proof-of-concept studies to large-scale global pivotal studies with seasonal follow-up, which are particularly useful to the study immunotherapies.

About Inflamax Research
Inflamax Research has been a leader in developing the validation and operating standards for EECs.

Briefly, they offer:

  •     100 Bed Phase I Clinic
  •     6 Environmental Exposure Chambers (EEC’s)
  •     Mobile EEC Option (mEEC™)
  •     Accelerated Proof-of Concept Studies
  •     Late Stage, Multi-center Global CTM Group
  •     Data Management, Stats, Medical Writing Services
  •     Regulatory Assistance
  •     Protocol Consultation and Study Design advice

Please contact Cynthia Day O’Brien for more information or to schedule a time to speak with Dr. Salapatek.

Inflamax Research CSO to Present Data Demonstrating the Utility of Environmental Exposure Chambers in Asthma & Allergic Rhinitis Research at ERS 2014

Dr. Anne Marie Salapatek, CSO at Inflamax Research, will be presenting clinical trial data demonstrating the utility of Environmental Exposure Chambers in asthma and allergic rhinitis research at upcoming 2014 European Respiratory Society conference in Munich, Germany, September 6-10.

Toronto, ON (PRWEB) September 04, 2014

Inflamax Research Inc., a full-service CRO, announced today that their Chief Science Officer, Dr. Anne Marie Salapatek, will be presenting clinical trial data demonstrating how Environmental Exposure Chambers (EECs) can be utilized for the development of clinical trial programs aimed at showing safety and efficacy without the need for costly, large scale field studies.

The data being presented, across three poster presentations, is a representation of study design types that demonstrates how baseline allergic rhinitis symptoms can be provoked consistently out of allergy season. Patients are treated with an investigational or already-approved product, and then provoked again post-treatment to determine the level of change in symptom scoring. One poster specifically showcases a new naturalistic asthma model to study mild asthmatics safely and consistently using the EEC.

Dr. Salapatek is an expert in the field of allergy research and designing studies for specific regulatory requirements to prove safety and efficacy. She understands the need for a system like the EEC to be able to conduct small pilot and proof-of-concept studies through to large scale global pivotal studies. “Using the controlled EEC system allows small, novel compound companies to large global pharma and everyone in between, to explore pathways and indications to build their product and clinical trial programs in a streamlined and cost-efficient manner. It is very exciting that we are currently in talks with regulators from all major regions to allow EEC data from Phase III pivotal trials to be accepted for registration.”

Please join Dr. Salapatek on Tuesday, September 9th at 12:50pm-2:40pm at poster session 414 (1 poster, Hall B2-28) and session 415 (2 posters, Hall B2-29). She welcomes the opportunity to discuss the research that can be conducted utilizing Inflamax Research’s EECs, and its application to your upcoming projects. We welcome all inqueries as to Inflamax Research’s services and experience as a full-service CRO.

About Inflamax Research

Headquartered in Toronto, ON, Inflamax is a full service Contract Research Organization (CRO) specializing in Proof of Concept, and Phase I to IV studies in allergy, asthma, ocular, healthy volunteer studies and dermatology. Inflamax has unique electronic data collection tools for single and multi-center EEC and field studies which greatly improve the quality and speed of data collection in clinical trials.

About Dr Patel

Dr. Piyush Patel, Inflamax’s CEO is an industry veteran who has been in the forefront of development in EEC technology. Dr. Patel is an author of several patents relating to EEC technology and has been involved in the development of many mainstay anti-allergy drugs and immunotherapies currently on the market. He was the owner of Allied Research International; a CRO specializing in EECs, which was sold in 2007. Dr. Patel was also named Entrepreneur of the Year in 2008 for his work in building that company.

Inflamax Research’s CSO presents at EAACI 2014

Dr. Anne Marie Salapatek, President & Chief Scientific Officer of Inflamax Research, will be presenting results of a meta-analysis outlining statistically significant correlations between house dust mite symptoms in the traditional Field trial approach and those collected from patients in the Environmental Exposure Chamber (EEC). These findings support the use of EEC allergen challenge approach for pivotal testing.

Mississauga, ON (PRWEB) June 06, 2014

Dr. Salapatek, an internationally renowned scientist with expertise in allergy, asthma and EEC clinical trials, is an invited speaker at the EAACI meeting. “This data shows that conducting studies in the EEC provides the best research option that reduces the variability seen in field trials whilst providing an accurate read of a therapy’s efficacy, and importantly also which well reflects that seen in the traditional field trial approach”, states Dr. Salapatek. These findings are to be presented at the 2014 The European Academy of Allergy and Clinical Immunology (EAACI) Congress in Copenhagen, Denmark on June 10th at 1:30 pm.

Dr. Salapatek will also be presenting a poster demonstrating that correlations between skin prick tests (SPT) and specific IgE levels in patients vary with perennial and seasonal allergies. This data was collected between Q4’2013 to the end of Q1’2014, when Inflamax successfully screened over 2,500 subjects for allergy studies including single and multi-site studies for seasonal and perennial allergy.

Inflamax Research is a leading CRO based in Mississauga Canada, specializing in Proof of Concept and Phase I through IV studies in allergy, asthma, ocular disease, and dermatology. Inflamax has successfully conducted studies in vulnerable and difficult-to-recruit populations, and allergy studies requiring very healthy participants. The results of these studies have been published in several mediums. Inflamax’s proprietary EEC and Electronic Patient Data Acquisition Tablet (ePDAT) has shown high controllability and compliance in comparison to traditional field studies and paper data collection.

The European Academy of Allergy and Clinical Immunology is an independent organization that does not endorse or refute claims made by presenters.

Inflamax Research, Inc. Announces Fully-Integrated Clinical e-Source Data Management Services

Advancement allows for clinical research data in agency-required format and the ability to
conduct full-service projects in house.

Toronto, ON October 24, 2013

Inflamax Research Inc., a full-service Contract Research Organization (CRO) specializing in Proof of Concept as well as Phase I through IV studies in allergy, asthma, ocular, and dermatology utilizing EEC technology is pleased to announce expansion of their e-Source Clinical Data Management (CDM) services.

The CDM team has experience with electronic data capture services, having built, released, and “locked” 375 databases since 2006 in multiple study designs and therapeutic areas. All team members are members of the Society for Clinical Data Management (SCDM) and all have achieved their Certified Clinical Data Manager (CCDM) status. The utilization of CDISC and CDASH standards provides the industry-standard data exchange models which facilitates submission for FDA requirements. In addition to a full complement of data management services, including web-based fully compliant 21 CFR Part 11 electronic data capture capability via secure Internet access, Inflamax Research Inc. has integrated its e-Source data capture in the clinic seamlessly into good data management practices. This includes Inflamax Research Inc.’s electronic Patient Data Acquisition Tablet (ePDAT™) in which patient-reported outcomes are input directly and then captured securely and directly into the database.

“Having a full-service CDM department allows Inflamax Research Inc. to offer, in addition to their clinical expertise and novel mobile Environmental Exposure Chamber (mEECTM) technology, the ability to provide clinical research data in agency-required format for potential submissions. This is a definite plus for those clients who want a cohesive service provider for their clinical trials”, states Denise Redkar-Brown, Inflamax Research Inc.’s Senior Director of Clinical Data Management.

“The addition of our fully-integrated e-Source data management services adds the ability to have full- service projects in house, but the teams’ experience in stand-alone clinical data management services allows Inflamax Research Inc. to expand our offerings to include that as well,” adds Derek Johnson, Director of Data Management for Inflamax Research Inc.

“I am excited to launch our fully-integrated e-Source data management services here at Inflamax Research Inc. This is only possible due to our strong data management expertise and leadership that we have here at Inflamax Research Inc. where we are truly developing state-of-the-art data management tools. Clinical safety and efficacy data management is core to a successful clinical trial. Our CDM experts will be involved early on in discussions about data collection options and will oversee the development of data collection tools based on the clinical trial protocol working closely with our sponsors. Inflamax Research Inc.’s CDM offerings will integrate seamlessly with our electronic data acquisition capabilities in the EEC and field in our multicenter trials, as well as provide standalone CDM services for those clients who require them, ” states Dr. Anne Marie Salapatek, President and Chief Scientific Officer of Inflamax Research Inc.

About the Inflamax Research Inc. CDM Team Leadership

Denise G. Redkar-Brown, Senior Director for Clinical Data Management, has over 25 years of experience in pharmacology and clinical research having worked on multiple compounds/vaccines that have been submitted and approved by the FDA. Presently, Denise is a trustee on the Society for Clinical Data Management (SCDM) Board of Trustees, chair of the SCDM On-line Learning Committee and facilitates multiple on-line courses for SCDM. In addition to scientific papers that appeared in journals such as The European Journal of Pharmacology and Prostaglandins, Denise has been published in the Good Clinical Practices Journal in April 2008 for her article “From Process to Project”, discussing the evolution of the Clinical Data Manager’s role in clinical research.

Derek Johnson, Director, Data Management is a Certified Clinical Data Manager (CCDM) through the Society for Clinical Data Management (SCDM) and has been overseeing Data Management operations for more than five years. During this time he has managed more than 350 eDC studies in phases I – IV, including specialization in Allergies (Environmental Exposure Chamber), First in Human, Drug Interaction, Dermatology and Thorough QT trials. In addition to his clinical data management experience, Derek brings 10+ years of management experience and extensive CDISC SDTM and CDASH experience. He has been involved in the submission of over 135 CDISC SDTM submissions. In 2011, he was invited to present at the Society for Clinical Data Management (SCDM) annual conference, “Hurdles Facing Early Phase CDM Utilizing eDC”.

Both Derek and Denise have been selected as Subject Matter Experts (SME) for the SCDM’s Good Clinical Data Management Practices (GCDMP) new chapter on Electronic Data Capture. The GCDMP which was awarded the Good Clinical Practice Journal (GCPJ) Award for “Most Successful Company or Program of the Year in Raising GCP Standards” in London (2007) is the current industry standard for clinical data management that consist of best business practices and acceptable regulatory standards.