Dscs CRO clinical trial services http://www.dscscro.com

1. DSCS CLINICAL TRIAL
SERVICES
“On Time and Under Budget!”
We can manage every clinical project through all stages from concept to final report.
We pride ourselves on taking over the more challenging trials and finding physicians who
currently treat the target patient population while simultaneously training them and
building their own infrastructure to conduct clinical trials.

2. Our Proven Model
Headquartered in Southern California, we are a full service CRO that
differentiates itself with our patient recruitment strategy for difficult to recruit
studies, and with our low overhead and operating costs when it comes to
the less demanding trials. We pass both of these benefits: cost savings and
rapid patient enrollment, on to the Sponsor. While the lower costs are self
explanatory (we simply do not have the overhead of most of our larger
competitors), our patient recruitment strategy is unique and worth a brief
explanation.

3. Patient Enrollment
The problem with most studies, as you are aware, are slow recruitment rates
amongst sites. The root of the problem, we believe, begins with site selection
and PI recruitment. We reverse engineer the desired patient population and
look for the physicians who treat a large volume of these patients across the
country. Our business development team will contact the physician and
partner with them on developing their own in house research department.

4. How It Works
Unlike the traditional SMO models of the past, our backbone is our network of home
based CRA’s that we have trained internally, and whom are remotely working for us in
every region of the country and are available for onsite monitoring as well as remote
monitoring around the clock. At current count we have 44 trained CRA’s, 3 Project
Managers, 5 Medical Monitors, and 4 Lead CRA’s. We also have a team dedicated
to contracts and another dedicated to regulatory affairs. We assign each newly
formed physician site their own CRA whose only job will be to monitor and help
provide the necessary training and operational oversight to ensure that the PI and
their study coordinators will have a successful first trial. We have even gone to the
extent of hiring and training the study coordinator for the PI or assisting in hiring an
already trained study coordinator. We have a full grasp of what it takes to operate a
research site as we also own and operate other research clinics across the country
through our other business units.

5. Services
While we are a full-service CRO, we understand that many Sponsors prefer to
choose certain services “à la carte”. We are looking to work with you on
your more challenging trials and hope to be able to assist in the patient
recruitment, site selection, site training, and monitoring oversight of these
sites as we pride ourselves on specializing in working with research naive
physicians. We also have a dedicated team that handles all of the back-
end activities that any clinical trial will require, such as data analysis, site
supply, investigational product logistics and accountability, and the like.

6. Clinical Trial Management –
Set-up and Monitoring
DSCS provides monitoring services that ensure your study is compliant with all
GCP, ethical and regulatory requirements. DSCS has a highly trained team of
CRAs to set-up and monitor your clinical trial starting with site feasibility and
site selection including the preparation of confidentiality agreements and
site contracts. The CRAs then work with the writing team to co-ordinate
ethics and regulatory submissions. The next stage is organizing investigator
meetings and conducting site initiation visits which are followed by regular
monitoring according to the approved monitoring plan. Recruitment status
and trial progress is tracked and CRAs maintain the electronic trial master file
(eTMF) throughout before finally conducting site close out visits. At all times
DSCS’s experienced CRAs work closely with the sites to ensure that your trial
is conducted to the highest standards and recruitment objectives are met.

7. Design
We are able to workshop ideas for your study with our team of experts. DSCS
statisticians/biostatisticians can provide initial clinical trial design advice,
sample size calculation and randomization schedules. Medical and scientific
writers then provide the necessary documents with the necessary GCP/ICH
standards (including the IB, protocol and informed consent) and our
specialized team prepares all ethics documentation to meet submission
timelines.

8. Past Performance/Experience
We have proven through our past decade of consulting experience that
we are able to successfully identify, train, and encourage research naive
physicians to conduct their first clinical research studies while not disrupting
their private practice operations in the process. To date, all of the
physicians whom we have set up a research operation for, have
continued to participate in further research studies. Due to our existing
infrastructure, we are able to maintain quality control while allowing the
Investigative sites to operate independently of us. This is the main
differentiator and what separates us from Site Management
Organizations.

9. Risk Based Monitoring and
Remote Monitoring
The next two slides will illustrate our biostatistics and data management
components which work 24/7 behind the scenes to allow for necessary
adjustments to be made to each site’s unique monitoring plan. Our home
based monitors are trained on using our own customized EDC platform and
CTMS systems provided by Bioclinica, as well as our virtual workspace
provided by Intralinks. This allows for real time source data verification, in
addition to an online eTMF which allows for seamless collaboration between
data management, our CRA’s, the research site and the Sponsor. All
systems are ICH and FDA 21 CFR Part 11 compliant.

10. Data Management
DSCS provides the full range of data management services from data
capture through validation and reporting. All of our experienced data
managers have postgraduate qualifications in Data Management. We have
also partnered with Bioclinica on their EDC platform. Our services include
case record form (CRF) design (eCRF and ePRO), database set-up, double
data entry, validation and generation of queries. Our MedDRA certified staff
code medication, medical history and adverse events using the latest
dictionaries and coding tools. Experienced coders use the WHO DD to code
concomitant medications. All systems are ICH and FDA 21 CFR Part 11
compliant.

11. Statistics
DSCS provides statistical consulting services to business, government and
academia. DSCS employs statisticians/biostatisticians, with postgraduate
qualifications in statistics. They regularly provide guidance in clinical trial
design, provide a statistical analysis plan (SAP), perform statistical analyses in
SAS, and provide tables, figures and listings which can be included in an ICH
standard (E3) full clinical study report (CSR).

12. Medical and Scientific Writing
DSCS provides specialized medical and scientific writing as well as editing
services. Our multidisciplinary team of experienced writers have all been
awarded the prestigious Certified Medical Publication Professional (CMPP)
qualification and are the authors of peer-reviewed journal articles, book
chapters, grant proposals and clinical study documentation. As an integral part
of clinical research, our medical writers produce the necessary documents
including protocol, IB, ethics and regulatory documents and the full CSR to ICH
standards. Publications are produced to journal standards and presentations,
scientific or technical documents, are written according to professional
guidelines. Acknowledgements of authorship at all times comply with ICMJE
guidelines.

13. Pharmacovigilance
DSCS provides pharmacovigilance services overseen by our medically
qualified personnel who can provide safety oversight for clinical trials,
including Data Safety Monitoring Board (DSMB) involvement, with full
services offered for start-up companies.

14. QA and Auditing
DSCS can arrange independent quality assurance (QA) and GCP auditing
and quality control of standard operating procedures (SOPs) anywhere in
the world. Our auditor partner has internationally recognized qualifications
and a wealth of experience.

15. THERAPEUTIC AREAS
· AIDS/HIV · alternate therapies · anti-infectives · cystic fibrosis ·
cardiovascular · diabetes · dermatology · devices · diagnostics · first-in-
humans
· gastroenterology · hematology and immunology · mental health ·
musculoskeletal · neurology · oncology · ophthalmology · pain · respiratory –
acute and chronic · reproductive technology

16. THE TEAM
DSCS boasts an integrated team of highly qualified and experienced
professionals including medical, pharmacy and drug development, statistics
and biostatistics, biological sciences, public health and IT graduates, most
with postgraduate qualifications. At current count we have 44 trained
CRA’s, 3 Project Managers, 5 Medical Monitors, and 4 Lead CRA’s.

17. STANDARDS
DSCS is committed to compliance with all international and local applicable
regulatory requirements for managing clinical studies. All studies are
conducted according to the International Conference on Harmonisation
Good Clinical Practice (ICH GCP) guidelines. All our data collection systems
are compliant with US Federal Drug Administration (FDA) code of
regulations, Title 21 CFR Part 11. We have quality management systems in
place to ensure excellent processes. Our systems are set up to ensure
security and protect confidentiality and privacy.

18. EXPERIENCE
DSCS and its executive team have worked on 100s of studies over the past two
decades. The two founders, Dan Sfera and Chris Sauber, have over two
decades of experience managing hundreds of clinical trials as site owners, site
directors, project managers, and consultants, amongst other capacities. We are
a niche CRO that works exclusively with small to mid-sized biotech companies.
Please take a moment to visit our website DSCSsweatEquity.com to learn more
about our capabilities or to request a proposal for an upcoming or existing trial.
Dan Sfera can be reached at (714) 318-5394 or at dan@theclinicaltrialsguru.com