Irfan Ullah CCRP[DISABLED]
Director of Clinical Research
North Dallas Research Associates
4201 Medical Center Drive, Suite 380
McKinney, TX 75069
North Dallas Research Associates is a dedicated clinical research site associated with an advanced state-of-the-art cardiology practice Cardiac Center of Texas.
For past 12 years, we have been conducting FDA approved pharmaceutical and device trials in a broad range of therapeutic areas for many industry leading pharmaceutical companies and clinical research organizations. We specialize in Phase I - IV outpatient and inpatient clinical trials. We also recruit clinical trials for other physicians in the area and operate as a satellite site.
We pride ourselves on delivering quality service in a timely fashion. Our mission is to improve health and quality of life for our community by providing superior and most reliable service to our patients and sponsors. At NDRA, we put together our knowledge, experience and hard work to promote drug development process in the prevention and cure of the disease.
Established in 2003 by M. Akram Khan MD, NDRA has grown steadily to build our expertise in clinical research operations to become one of the leading clinical research sites. We are a team of professional and dedicated staff, who manages and conducts a vast variety of clinical trials.
At NDRA, we don’t make a commitment until we are absolutely sure to deliver the results. We have a reputation of accepting difficult protocols and fulfilling our promise by providing highly compliant data with maximum enrollments. On multiple occasions, NDRA has been ranked amongst top enrollers, ahead of many other nationally recognized clinical research facilities. Our subject retention rate is close to 100% on all our clinical trials.
Currently, the site has three principal investigators conducting clinical trials under various specialties.
Our cardiovascular trials are being performed under guidance of Dr. Khan. Major cardiovascular related research includes conditions like hypertension, hyperlipidemia, coronary artery disease, peripheral artery disease, atrial fibrillation, congestive heart failure, obesity, Coronary stents, peripheral stents, pacemaker implants, ICDs, PFO closures, etc.
While, team for neurovascular trials is led by Dr. Khalid who specializes in Stroke, Alzheimer’s, Multiple Sclerosis, Parkinsonism and other neurological disorders.
Dr. Ashfaque is responsible to conduct research trials ranging from studies in phlebology, rheumatology, nephrology, pulmonology, allergy/asthma, gastroenterology, genetic disorders etc.
Pharmaceutical companies and CROs that we have worked with:
North Dallas Research Associates is located 30 miles north of Dallas downtown in the fast growing McKinney area, which is easily accessible for all age groups. The closest hospital with full-service 24/7 emergency department and a cardiac catheterization lab is located across the street from our site.
We have a database of close to 20,000 patients that include private patients, volunteers who have participated in clinical trials or those who have expressed interest in clinical trials. Besides this, site is privileged to have a well-established network of primary physicians in the area who routinely send patients for possible research enrollments. Our site has the following features:
Note: Annual maintenance of all our research equipments is mandatory and we maintain a separate binder for all such calibration records.
Following features at our site has enhanced our capability to provide services to our sponsors and conduct wide range of drug and device trials:
All our principal investigators are experts of their assigned protocols and are very well familiar with our standard operating procedures. They are committed to dedicate sufficient time and efforts to run clinical research operations at the site. The investigator led weekly staff meeting is a great source of group discussion between research staff to ensure each clinical research protocol is being followed appropriately and the site has been successfully achieving enrollment goals by maintaining high standards of data compliance and subject safety. All subject and non-subject related events are thoroughly discussed and the suitable plan of action is put in place if required.
M. Akram Khan MD FACC:
Dr. Khan has been practicing cardiovascular medicine in McKinney, Texas since 1997 after successfully completing his interventional cardiology fellowship at Baylor Medical Center, Dallas. He is the founder of North Dallas Research Associates, which was established in 2003. Since then, Dr. Khan has performed leadership role in over 30 cardiovascular trials as a principal investigator that involves both drug and device studies. Dr. Khan has shared his clinical and regulatory experience being a member of an IRB for many years at the local community hospital. Being a certified clinical research professional from SOCRA, he firmly believes in the need for physicians to have proper training in the research field so as to stay compliant with FDA regulations and GCP guidelines.
Shahram Khalid MD FACC:
Dr. Khalid is a board certified neurologist from Wayne State University; Detroit MI. Dr. Khalid is part of a very busy neurology practice in Plano, TX and likes all aspects of Neurology but particularly taking care of critical care neurology patients at the hospital. He has special passion for stroke and delivering acute care to minimizing the effects of this devastating condition. He likes to do noninvasive vascular procedures like carotid ultrasounds and educating patients about preventive care. He works mainly out of Medical Center of Plano. North Dallas Research Associates collaborates with Dr. Khalid and his team to conduct wide range of neurovascular trials.
Ambreen Ashfaque MD:
Dr. Ambreen Ashfaque came on board with our facility in December of 2010 but has been around the clinic since 2003. She is a graduate of Dow Medical College and attended UT Southwestern Medical School where she did her internship and family medicine residency. Dr. Ashfaque has recently become certified by the American Board of Venous and Lymphatic Medicine adding this to her list of professional accomplishments. Dr. Ashfaque is very motivated and goal oriented towards clinical research. She plays a lead role to conduct all our non-cardiovascular trials.
Cortney Hanson PA-C:
Cortney grew up in McKinney and attended Texas A & M University where she gained her Bachelor of Science degree in Community Health. She then went to Physician Assistant School at the University of North Texas Health Science Center in Fort Worth and graduated in May 2010. She worked with Dr. Khan in the hospital setting prior to joining the facility in May 2012, and they have known each other over 10 years now. Cortney has been an integral part of our research team and provide clinical support on various studies as a sub investigator. Outside of work she enjoys working out, painting, traveling and spending time with her family.
The role of clinical research coordinator is a critical component in all studies. NDRA’s highly skilled staff is well versed in conducting everyday clinical trial operations. From start-up to close-out, our experienced clinical coordinators perform assigned clinical research procedures under direct guidance of Principal Investigators to ensure proper subject screening, trial conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.
Irfan Ullah MD CCRP:
Irfan earned his medical degree as an international medical graduate and joined NDRA as the Director of Clinical Research in 2010. Having a strong clinical background and being a certified clinical research professional from SOCRA, Irfan has taken our site to an entirely different level. Irfan is responsible to supervise all clinical trial activities ranging from site selection, budget negotiation & contract execution, regulatory work up and trial conduct. With Irfan's help, we are able to maintain excellent compliance for all our clinical trials. He considers data compliance and subject safety as our top priority.
Ahmed Ladak MD CCRP:
Ahmed is a Certified Clinical Research Professional from SOCRA. Ahmed has earned his Bachelor Degree in medicine and surgery and Residency in Cardiac Surgery from Pakistan. Ahmed has joined NDRA to continue with his passion for research and helping others. Ahmed is one of the lead clinical research coordinator at the site. He is compassionate in working with patients and efficiently handles various clinical studies. His hobbies are listening to music, travelling and spending time with family and friends.
Yasmeen Akhtar MD MS:
Yasmeen recently joined NDRA as a Clinical Research Coordinator. Yasmeen is an ECFMG certified medical graduate from Dow Medical College and completed her Masters Degree in Neurosciences from the University of Texas at Dallas. Yasmeen has experience working in clinical research in many geriatric conditions including chronic obstructive lung disease and Alzheimer’s disease. She has also assisted in animal studies of Autism at UT Southwestern as part of her graduate studies.
Andrew Awad MD:
Andrew grew up in Egypt where he attended medical school and graduated in 2012. He moved to the U.S. in 2012 and started working towards his medical boards. Andrew got ECFMG certified in 2014 and now he is seeking to get residency position in internal medicine. Meanwhile, Andrew joint our team at NDRA as a clinical research coordinator in February 2015 based on his medical knowledge background. Andrew is a fast learner. He has shown ability to quick learn and implement clinical research principles to effectively manage and solve multiple complicated research tasks. Andrew enjoys working for cardiovascular research. His hobbies are traveling and spending time with family and friends.
Saba has been with NDRA since 2012 as an Assistant Research Coordinator. Dedicated towards advanced cardiac research, she has a caring and nurturing manner with patients. Saba has handled many research studies and is now perusing her Clinical Research Coordinator’s Certification. A Chicago native, she has studied medical assisting, phlebotomy, and has owned her own restaurant.
Subjects visit at our site from Dallas Fort Worth metro area and the suburbs of Collin County reaching a minimum of a 40-mile radius. Over the past few years, the area has experienced a significant increase in population growth and this trend is expected to continue due to our affordable cost of living standards, nice climate, and economic development. The population is very diverse in race, career, socioeconomic and education levels making us very successful in fulfilling enrollment criteria. The response of our community in the basic understanding and need of clinical research in human beings is very positive and encouraging.
The patient population breakdown at our site consists of:
Our site has maintained standard operating procedure to conduct every aspect of clinical research in accordance with FDA regulations and GCP guidelines. All our SOPs are periodically reviewed and updated in a timely fashion.
Subject compliance plays a key role in success of any clinical trial especially clinical outcome trials where each lost to follow up is considered as a dead subject, which severely compromises the sponsor cause and validity of research data. NDRA is fully aware of this fact and we have maintained trust of our sponsors by achieving highest subject compliance rate on all our clinical trials.
We utilize central IRB for all our outpatient studies for rapid turnaround. All our inpatient studies come under jurisdiction of local IRB affiliated with The Medical Center of Plano hospital. We understand importance of strict study timelines. On an average, we complete regulatory work up and contract execution within 4 weeks of site approval and receipt of regulatory documents. We start screening our subject database prior to site initiation visits. Till to date, we have met our enrollment goals for all our trials; quite frequently we lead the trials as top enroller among our peers.