Indication: Gastroenterology
Memphis Gastroenterology Group - Germantown, TN
- Over 30 years of clinical research experience in indications
including: IBS, GERD, EE, Hepatitis C, Crohn’s Disease, Ulcerative
Colitis, dyspepsia, sedation, bowel cleansing
- 1 primary investigator and 9 sub-investigators
- Certified outpatient endoscopy center performing upper GIs,
colonoscopies, enteroscopies, endosonography, capsule endoscopy,
and a CT scan in preparation for the advent of virtual
colonoscopy
- Physicians perform approximately 60 endoscopies per day
- Approximately 9,000 new patients seen per year
Gastrointestinal Associates - Jackson, MS
- Over 10 years of clinical research experience in indications
including: IBS, GERD, EE, Crohn’s Disease, Ulcerative Colitis,
dyspepsia, sedation
- 8 primary investigators whom serve as sub-investigators on each
other’s trials
- Physicians perform 85 to 100 endoscopies per day
- Practice is capable of performing upper GIs, colonoscopies,
enteroscopies, endosonography and capsule endoscopy
- Approximately 10,000 new patients seen per year
The Frist Clinic - Nashville Gastroenterology, Nashville, TN
- 1 primary investigator and 6 sub-investigators
- Over 5 years clinical research experience
- Perform upper endoscopies, colonoscopies and capsule endoscopies
- Approximately 6,000 new patients seen per year
The Jackson Clinic - Jackson, TN
- Over 3 years of clinical research experience in indications
including: IBS, GERD, EE
- 2 primary investigators whom serve as sub-investigators on each
other’s trials
- Practice is capable of performing: upper endoscopies,
colonoscopies and flexible sigmoidoscopies
- Approximately 800 new patients seen per year
Indication: Cardiology
Centennial Heart - Nashville, TN
- Over 6 years clinical research experience in indications
including: Coronary Artery Syndrome, Acute MI, Coronary Artery
Lesions, Vein Grafts, and Percutaneous Coronary Interventions
- 8 primary investigators whom serve as sub-investigators on each
other’s trials
- Practice is capable of performing: nuclear scans, EKGs,
echocardiograms, MUGA scans, vascular ultrasounds, Venous Doppler,
treadmill studies, pacemaker/ICD evaluations
- Experience in Percutaneous Coronary Interventional clinical
trials
- Approximately 1,000 new patients seen per year
Indication: Internal Medicine
The Sarah Cannon Research Institute- Research Center- Germantown, TN
- Center is capable of performing: labs, x-rays, EKGs, CT scans, DEXA scans, PTF, standard treadmill tests, nuclear medicine for treadmill studies, Venous Doppler, echocardiograms
- New Research Center affiliated with a high volume Internal Medical Practice
- Approximately 1,500 new patients seen per year
The Jackson Clinic - Jackson, TN
- Over 3 years of clinical research experience in indications
including: osteoarthritis, restless legs syndrome, obesity,
dyslipidemia, hypertension
- 5 primary investigators whom serve as sub-investigators on each
other’s trials
- Practice is capable of performing: labs, x-rays, EKGs, CT
scans, DEXA scans, Holter monitoring, vascular and echo
ultrasonography, MRIs, nuclear medicine
- Approximately 1,600 new patients seen per year
Indication: OB/GYN
Gynecology & Obstetrics - Memphis, TN
- Over 3 years of clinical research experience in indications
including: oral contraception, menopause, HPV, genital herpes,
osteoporosis, vaginal atrophy, overactive bladder, vaginitis
- 1 primary investigator and 7 sub-investigators
- Practice is capable of performing: labs, x-rays, EKGs,
ultrasounds, mammography
- Approximately 2,000 new patients seen per year
The Jackson Clinic - Jackson, TN
- Over 3 years of clinical research experience in indications
including: oral contraception, menopause, vaginal atrophy,
endometriosis, urinary incontinence, vaginitis
- 1 primary investigator and 1 sub-investigator
- Practice is capable of performing: labs, x-rays, EKGs,
ultrasounds, digital mammography with ICAD
- Approximately 800 new patients seen per year
Indication: Dermatology
Dermatology East - Germantown, TN
- Over 7 years of clinical research experience in indications
including: psoriasis, onychomycosis, warts, tinea capitis,
sunscreen, rosacea, athlete’s foot
- 1 primary investigator and 1 sub-investigator
- Practice is capable of performing: labs and photodynamic
therapy
- Approximately 100 new patients are seen each year
Indication: Allergy / Asthma and ENT
The Jackson Clinic (Allergy / Asthma) - Jackson, TN
- Over 4 years of clinical research experience in indications
including: seasonal allergic rhinitis, flu vaccine, asthma
- 1 primary investigator and 2 sub-investigators
- Practice is capable of performing: labs and PFTs (two
machines)
- Approximately 400 new patients seen each year
The Jackson Clinic (ENT) - Jackson, TN
- Over 3 years of clinical research experience in indications
including: acute sinusitis, acute otitis media
- 1 primary investigator and 2 sub-investigators
- Practice is capable of performing: labs, x-rays, and has a
licensed audiologist
- Approximately 1,000 new patients seen each year
Indication: Pediatrics
The Jackson Clinic - Jackson, TN
- Over 3 years of clinical research experience in indications
including: ADHD, RSV vaccine, constipation, flu vaccine, acute
otitis media, formula intolerance, asthma, tinea capitis
- 1 primary investigator and 3 sub-investigators
- Practice is capable of performing: labs and x-rays
- Approximately 100 new patients seen each year
Indication: Oncology and Hematology
Tennessee Oncology - Nashville, TN
- Located in middle-Tennessee with 25 practice locations.
- Clinical research is conducted at 11 locations which are
staffed with oncology research nurses.
- 46 community-based physicians (Medical Oncologists and
Hematologists).
- Over 10,500 new patients each year, representing all tumor
types.
- This practice has capabilities and experience conducting phase
I, II, III, and IV clinical trials.
- On average, 1,000 patients are enrolled annually.
- Sponsor monitoring is conducted out of one central office (250
25th Avenue North, Suite 110, Nashville, TN). Original charts and
CRFs always remain at the central location for the monitoring.
- Site has centralized pharmacy for drug shipment, staffed by a
dedicated research pharmacist. Drug is then transported to the
satellite office once a patient has been identified, screened, and
is ready to enroll.
Florida Cancer Specialists (FCS) - Fort Myers, FL
- Located in Southwest Florida from Bradenton to Naples with 14
practice locations.
- Clinical research is conducted at 13 locations which are
staffed with oncology research nurses.
- 43community-based physicians (Medical Oncologists and
Hematologists).
- Over 17,500 new patients each year, representing all tumor
types.
- This practice has capabilities and experience in conducting
phase II, III, and IV clinical trials.
- On average, 300 patients are enrolled annually.
- Sponsor monitoring is conducted at each satellite location
where subjects are enrolled. Original charts and CRFs are available
at the central office for review.
- Site has centralized pharmacy for drug shipment. Drug is then
transported to the satellite office once a patient has been
identified, screened, and is ready to enroll.
Oncology Hematology Care, Clinical Trials, LLC (OHC) - Cincinnati, OH
- Located in greater Cincinnati with 18 practice locations.
- Clinical research is conducted at 9 locations which are staffed with oncology research nurses.
- 45 community-based physicians (Medical Oncologists, Hematologists, Neuro-Oncologists, GYN Oncologists, and Radiation Oncologists).
- 12,500 new patients each year, representing all tumor types.
- This practice has capabilities and experience in conducting phase II, III, and IV clinical trials.
- On average, 250 patients are enrolled annually.
- Sponsor monitoring is conducted at site where patient is enrolled. Original charts and CRFs are available at each location for review.
- Site has centralized pharmacy for drug shipment. Drug is then transported to the satellite office once a patient has been identified, screened, and is ready to enroll.
Chattanooga Oncology and Hematology Associates (COHA) -
Chattanooga, TN
- Located in Chattanooga, TN with 4 practice locations.
- Clinical research is conducted in 4 locations which are staffed
with oncology research nurses.
- 6 community-based physicians (Medical Oncologists and
Hematologists).
- 4,000 new patients each year, representing all tumor
types.
- This practice has capabilities and experience in conducting
phase II, III, and IV clinical trials.
- On average, 75 patients are enrolled annually.
- Sponsor monitoring is conducted at site where patient is
enrolled. Original charts and CRFs are available at each location
for review.
- Site has centralized pharmacy for drug shipment. Drug is then
transported to the satellite office once a patient has been
identified, screened, and is ready to enroll.
South Carolina Oncology Associates, PA (SCOA)- Columbia, South Carolina
- Located in Columbia, South Carolina with 1 practice location
- Clinical research is conducted in this location which is staffed with oncology research nurses.
- 20 community-based physicians (Medical Oncologists, Hematologists, Radiation Oncologist and Gynelogical Oncologist)
- 5,600 new patients each year, representing all tumor types
- This practice has capabilities and experience in conducting phase II, III, and IV clinical trials.
- Sponsor monitoring is conducted out of the central office. Original charts and CRF’s are at the central location for the monitoring.
- Site has centralized pharmacy for drug shipment.
Virginia Cancer Institute (VCI) - Richmond, VA
- Located in Richmond, VA with 4 practice locations
- Clinical research is conducted in 4 locations which are staffed
with oncology research nurses.
- 15 community-based physicians (Medical Oncologists and
Hematologists)
- 5,000 new patients each year, representing all tumor types
- This practice has capabilities and experience in conducting
phase II, III, and IV clinical trials.
- On average, 100 patients are enrolled annually.
- Sponsor monitoring is conducted at site where patient is
enrolled. Original charts and CRF’s are available at each location
for review.
- Site has centralized pharmacy for drug shipment. Drug is then
transported to the satellite office once a patient has been
identified, screened, and is ready to enroll.
SCRI Leadership
Dee Anna Smith, CPA, Chief Executive Officer
With over a decade of experience in clinical research, Dee Anna is responsible for carrying out the overall
strategic mission and vision for the organization. She joined SCRI in 2005 as chief information officer and also
served as president of SCRI Services, leading the development of corporate strategy and vision for that division
of SCRI. Prior to joining SCRI, she served as chief executive officer of Summit Research Solutions, a
multi-specialty site management organization that she co-founded in 1996. SCRI acquired Summit Research Solutions
in 2005. Beginning in 1998, she also served as chief executive officer of SiteWorks Solutions, another company
she founded, providing customized, web-based site management systems for the clinical trials industry. She sits
on the Board of Directors for Paragon National Bank and the Board of Visitors for the Lipscomb School of
Pharmacy. She received her Bachelor of Science degree in Accounting in 1986 from Pepperdine University in Malibu,
CA, and is a certified public accountant.
Phil Cestaro, CPA, Chief Financial Officer/Chief Information Officer
Prior to joining SCRI as Chief Financial Officer/Chief Information Officer, Phil served as Director, Product
Management, for Oracle Corporation, where he directed multiple project teams focused on the life sciences
industry and shaped the product strategy of Oracle’s Life Sciences suite of applications. Among his
accomplishments are raising millions of dollars in private investment for SiteWorks Solutions; growing SiteWorks
to become a leading application provider serving major academic centers and large pharmaceutical companies; and
co-negotiating the sale of SiteWorks Solutions to Oracle Corporation. He is also a Certified Public
Accountant.
Howard A. “Skip” Burris, III, M.D., Chief Medical Officer; Director, Drug Development
In addition to serving as chief medical officer and director, drug development for SCRI, Dr. Burris is a partner
with Tennessee Oncology, PLLC. He received his undergraduate degree from the U.S. Military Academy, West Point in
1981, and medical degree from the University of South Alabama in 1985. He then completed his residency and
fellowship in hematology/oncology at Brooke Army Medical Center in San Antonio, TX. While there, he served as
director of clinical research at the Institute for Drug Development of the Cancer Therapy and Research Center,
and was an associate professor at the University of Texas Health Science Center. He joined Tennessee Oncology in
1997 to initiate the Drug Development Program. His research interests have focused on the development of
investigational agents.
John D. Hainsworth, M.D., Chief Scientific Officer
Dr. Hainsworth is currently the chief scientific officer at SCRI and a partner with Tennessee Oncology, PLLC. He
received a Bachelor of Arts degree from Stanford University, followed by a medical degree from Vanderbilt
University. After completing an internal medicine residency and a medical oncology fellowship, he remained at
Vanderbilt as a faculty member in the Oncology Division from 1981–1993. In 1993, he and Dr. F. Anthony Greco left
Vanderbilt to become directors of the newly established Sarah Cannon Cancer Center. He has a wide variety of
clinical research interests and has published extensively in the areas of lung cancer, unknown primary cancer,
and lymphoma. Recent work has resulted in expanded roles and innovative uses for several new drugs including
docetaxel, gemcitabine, rituximab, and bevacizumab. As chief scientific officer, he is responsible for the
scientific progress of SCRI including protocol development, data analysis and manuscript preparation.
Margaret Mazzone, Vice President, Legal Counsel and Ethics and Compliance Officer
Meg is an attorney with more than 25 years of experience in the healthcare industry. Before joining SCRI in 2005,
she was a founder and served as chief administrative officer and general counsel for Healthcare Management
Directions, a startup company that develops and operates acute care hospitals emphasizing exceptional service and
productivity. Earlier in her career she served as legal counsel and ethics and compliance officer for Quorum
Health Group and as legal counsel for HCA. She graduated from Brown University and from Boston University School
of Law.
Jennifer Cole, Senior Director, Clinical Operations
With over ten years experience in the healthcare industry, Jennifer has primarily served in operations working
directly with physician sites and pharmaceutical companies. As senior director, clinical operations for SCRI, she
oversees Program Development, Regulatory and Clinical Operations for both the non-oncology and oncology lines of
business. Previously, she held the title of director, clinical operations, non-oncology for SCRI. She received a
Bachelor of Science in Nursing from the University of Memphis.
Patricia S. Graham, Senior Director, SCRI Oncology Research Consortium
Patricia possesses over 15 years of direct oncology clinical research experience in the administrative
operations, quality assurance, data management, trial development, project management, clinical patient and site
management of pharmaceutical, investigator-initiated and National Cancer Institute cooperative group-sponsored
trials. In her role as senior director, SCRI Oncology Research Consortium, she oversees SCRI-sponsored clinical
research trial operations including the divisions of SCRI Consortium Network Management, General Trial
Operations, Data Management, Regulatory and Safety Management. She previously held the title of director of
Regulatory Affairs and Program Development. She is CCRP certified through the Society of Clinical Research
Associates and holds a bachelor’s degree in Health Services Administration from the College of Business at
Florida Atlantic University.
F. Anthony Greco, M.D., Director of Sarah Cannon Cancer Center
During his tenure at Sarah Cannon, Dr. Greco has treated thousands of patients and undertaken hundreds of
research studies. Specializing now in cancers of unknown primary origin, lung cancer and germ cell tumors, his
principal professional interest has been clinical cancer research. He has helped to define the complex group of
patients with unknown primary cancer recognizing many subsets of patients that are different requiring specific
therapy. He has developed or helped develop new and improved therapies for patients with several types of
neoplastic diseases, including small cell lung and non-small cell lung cancer, ovarian cancer, germ cell tumors,
neuroendocrine tumors and unknown primary cancer. His undergraduate and medical degrees were both received from
West Virginia University. He completed his internship at the University of California, Los Angeles and residency
at West Virginia University Medical Center, both in internal medicine. He then earned a fellowship in medical
oncology from the National Cancer Institute.
Denise A. Yardley, M.D., Director of Breast Cancer Research
Dr. Yardley received her Medical Degree from The Medical College of Georgia. She completed her residency and
fellowship training at The University of Texas, Southwestern Medical Center in Dallas, Texas where she remained
as a Faculty Member. She served as Director of the UT Southwestern Center for Breast Care before relocating to
The Sarah Cannon Research Institute as the Director of Breast Cancer Research. A diplomat of the American Board
of Internal Medicine, Medical Oncology and Hematology, she also received the American Cancer Society Clinical
Oncology Career Development Award. Dr. Yardley is nationally recognized for her work in the treatment of advanced
and HER2+ breast cancer.
David Spigel, M.D., Director of Lung Cancer Research
Dr. Spigel completed medical school at the University of Tennessee in Memphis after attending college at Tulane
University. He completed his internship, residency and chief residency in Internal Medicine at Indiana University
Medical Center in Indianapolis, followed by a fellowship in hematology/oncology at the Dana-Farber Cancer
Institute in Boston. His clinical research interests include gastrointestinal, thoracic and breast cancers.
Johanna Bendell, S.B., M.D., Director of GI Cancer Research; Associate Director, Drug
Development
Dr. Bendell has a leadership role in the SCRI Drug Development Unit and brings extensive Phase I experience from
her work at Duke University, where she served as assistant professor of medicine. She is board certified in
internal medicine and medical oncology and received her undergraduate and medical degrees from the University of
Chicago. She completed her internship and residency in the Department of Internal Medicine at Brigham and Women’s
Hospital in Boston, MA, as well as a fellowship in adult oncology at Boston’s Dana-Farber Cancer Institute. After
finishing her training, she served as assistant of medicine at Massachusetts General Hospital and instructor in
medicine at Harvard Medical School. She is a member of the American Society for Clinical Oncology and the
American Medical Association.
Jeffrey R. Infante, M.D., Associate Director, Drug Development
Dr. Infante is board certified in internal medicine and medical oncology. He came to SCRI from Johns Hopkins
University, where he was chief fellow of medical oncology and a member of the fellowship advisory committee. He
received his undergraduate and medical degrees from the University of Florida and completed his residency at
Parkland Memorial Hospital, University of Texas Southwestern Medical Center. Following residency, he obtained
formal training in patient-oriented research and clinical trial design while completing a Master of Health
Science degree in Epidemiology at Johns Hopkins University’s Bloomberg School of Public Health. His interests
include investigational agents and advanced solid tumor malignancies. In his role at SCRI, he adds expertise to
the Drug Development Unit team and helps expand other solid tumor programs.
Suzanne Jones, Pharm.D., Scientific Director, Drug Development
Dr. Jones oversees conduct of trials in the DDU, including pharmacokinetic/ pharmacodynamic studies. She was
recruited from GlaxoSmithKline in 1998, with prior experience as director of the Investigational Drug Section at
the Institute for Drug Development in San Antonio, Texas. She received her undergraduate degree from the
University of North Carolina at Chapel Hill in 1987 and her doctor of pharmacy degree from the University of
North Carolina at Chapel Hill in 1989. She then completed her residency and fellowship in hematology/oncology at
the Audie L. Murphy Veteran's Hospital and the University of Texas Health Science Center in San Antonio, TX. Her
research interests have focused on the development of investigational agents.
Gautam Rao, M.D., Director, GYN Oncology
Dr. Gautam Rao received his medical degree from the University of Miami in 1997. He completed his OB/GYN
residency at Wayne State University in Detroit, Michigan in 2001. He then earned a fellowship in 2005 at the
University of Texas South, Western Medical Center. From 2005-2007 he served as assistant professor of Obstetrics
and Gynecology at Vanderbilt University Medical Center. He joined SCRI in March, 2008 as the lead researcher for
the GYN Oncology division.
Ian W. Flinn, M.D., Ph.D., Director of Hematologic Malignancy Research, Sarah Cannon Blood and Marrow
Transplant Program
Dr. Flinn came to SCRI from The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. He directs the
hematologic malignancy research program for the Sarah Cannon Blood and Marrow Transplant Program. He received his
Bachelor of Arts degree in Economics from Georgetown University in Washington, D.C. and attended medical school
at Johns Hopkins University School of Medicine in Baltimore, MD. Following, he completed his internship and
residency in the Department of Internal Medicine at the University of Michigan Medical Center in Ann Arbor, MI.
He then earned a fellowship in oncology and hematology and a Ph.D. in clinical investigations from Johns Hopkins
University School of Medicine. The clinical research focus of the Sarah Cannon Blood and Marrow Program includes
the exploration of novel therapies in patients with all types of hematologic malignancy.
Daniel Couriel, M.D., Director of Transplantation Research, Sarah Cannon Bone Marrow Transplant
Program
Dr. Couriel received his medical degree from Universidad de Buenos Aires School of Medicine in Argentina. He
completed his residency in internal medicine at Hospital de Clinicas Jose de San Martin, Universidad de Buenos
Aires; followed by a fellowship in hematology/oncology at St. Elizabeth’s Medical Center, Tufts University School
of Medicine, in Boston; and a fellowship in the leukemia unit at Johns Hopkins Oncology Center, Johns Hopkins
University School of Medicine, in Boston, where he also com¬pleted a fellowship in the bone marrow
transplantation unit. Dr. Couriel’s research is focused on new treatment approaches for acute and chronic
graft-versus-host disease (GVHD), the 2 major obstacles to successful allogeneic transplant.
Jesus G. Berdeja, M.D., Director of Leukemia Research, Sarah Cannon Blood and Marrow Transplant
Program
Dr. Berdeja serves as director of leukemia research and a principal investigator for the Sarah Cannon Bone Marrow
Transplant Program. Previously, he worked as assistant professor of medicine at Loma Linda University. Dr.
Berdeja received his undergraduate degree from Stanford University and medical degree from Harvard University. He
completed his internship and residency in the Department of Internal Medicine at the University of California in
San Francisco. He also completed fellowships in medical oncology and hematology at Johns Hopkins University in
Baltimore. After his training, Dr. Berdeja served as clinical associate at a University of California satellite
clinic in San Francisco and attending physician at Summit Hospital in Oakland, CA. Dr. Berdeja is board certified
in internal medicine, medical oncology and hematology.
Non-Oncology
Lawrence D. Wruble, M.D., F.A.C.P., F.A.C.G. ., Medical Director, GI ResearchDr.
Wruble is the medical director of GI research. A graduate of the University of Tennessee School of Medicine, he
is clinical professor of medicine and former acting chairman for the Department of Gastroenterology at the
University of Tennessee Center for the Health Sciences. He is also president and senior physician at Memphis
Gastroenterology Group and Memphis Gastroenterology Endoscopy Center in Memphis, TN. He has over 30 years of
successful experience in clinical research and is board certified in Internal Medicine and Gastroenterology.
Steven Manoukian, M.D., F.A.C.C., F.S.C.A.I. Director, Cardiovascular Research
Dr. Manoukian most recently served as assistant professor of medicine at Emory University and director of
interventional cardiology at Emory Crawford Long Hospital in Atlanta. After receiving his undergraduate degree
from Saint John’s University and medical degree from New York University, both in New York City, Dr. Manoukian
served his residency and chief residency in the department of internal medicine at the State University of New
York at Stony Brook. He also completed fellowships in cardiology and interventional cardiology at Emory
University. Dr. Manoukian is a fellow of the American College of Cardiology and Society for Cardiovascular
Angiography and Interventions and is board certified in internal medicine, cardiology and interventional
cardiology. He joins SCRI strategic investigative site, Centennial Heart.
Building upon our therapeutic expertise and our extensive
experience in conducting Investigator Initiated Trials in
partnership with pharmaceutical companies, SCRI is now providing
outsourced clinical development services to the pharmaceutical
industry. This initiative is called SCRI Services.
These services include, but are not limited to:
|
Study Planning
Project Management
Drug Safety Surveillance
Data Management |
Protocol Development
Site Management
Quality Assurance
Data Analysis |
Biostatistics
Clinical Monitoring
Regualtory Affairs
Medical Writing |
All of these services can be part of an integrated, full
service, trial management program or a subset of services can be
selected. SCRI Services is dedicated to providing the highest
quality services to pharmaceutical companies in a timely and cost
efficient manner to meet drug development needs. Our Team
approaches every project with a focus on quality and service.
Indicated below is additional information regarding selected
services we provide:
Study Design and Preparation:
SCRI’s researchers can assist with all phases of protocol design
from concept to final draft. We create Informed Consent templates,
design Clinical Research Forms, develop Patient Diaries, as well
as, write and develop Study Reference and Pharmacy Guides.
Pre-study Site Selection and
Qualification:
SCRI’s reputation for excellence allows us to continue to forge
strategic relationships with many of the best research sites in the
country. Our proven experience enables us to efficiently and
effectively qualify interested sites. We add value to a site’s
research operations by coordinating and tracking all aspects of
study start up, including IRB submission, regulatory document
completion, and investigative study drug release.
Site Contracting Services:
SCRI maintains in-house legal counsel to expedite negotiations of
clinical trial agreements with sites on behalf of clinical trial
sponsors. Examples of our assistance includes: drafting master
clinical trial agreements, negotiation of contracts and budgets,
providing investigator payment support services.
Clinical Monitoring Services:
We provide full service clinical trial monitoring including site
qualification, site initiation, routine monitoring, and site close
out. SCRI’s monitors are selected for their therapeutic expertise
and demonstrated experience. All SCRI monitors receive perpetual
training to meet both SCRI and sponsor standards.
Data Management:
SCRI has the experience to provide a complete spectrum of data
management services. Our systems and processes are developed with
the highest quality deliverable in mind. We can easily accommodate
traditional paper-based case report forms using Oracle® Clinical as
well as electronic data from laboratories, IVRS systems, CTMS
systems and other external sources. In addition to traditional data
management support, we also provide medical coding using MedDRA and
WhoDrug, and scanning of CRFs and queries.
Biostatistics:
Our Biostatisticians can provide quality support for statistical
planning, analyses and reporting. Our service options range from
basic to advanced, multilevel statistical analysis. SCRI
specializes in sample design, size and power calculations.
Project Management and Site Management:
Each sponsor project undertaken by SCRI Services is assigned a
Project Manager who ensures that all aspects of the project are
executed in accordance with the scope of work, protocol, SOPs and
ICH/GCP regulations and guidelines. Our Project Managers form
strong partnerships with sponsor teams in order to maximize
efficiencies between sponsor and SCRI processes and technologies.
SCRI Project Managers provide assistance with development of study
and monitoring plans, study status reporting, coordination of team
meetings, coordination and tracking of site selections and
monitoring visits, study risk assessments, contingency planning,
and oversight of study documentation.
Serious Adverse Event Reporting:
SCRI’s provides a full complement of drug safety activities and
documentation including collection and processing of SAE reports,
IND safety report preparation and distribution, and notifications
to regulatory agencies.
Quality Assurance:
The SCRI Quality Assurance Team not only maintains a comprehensive
internal quality program, but also offers Investigative Site Audits
as a service to clinical trial sponsors. Investigative site
documentation, research records and drug accountability logs are
thoroughly assessed to ensure that a clinical trial is being
conducted in accordance with applicable regulations and
guidelines.
