2011 EmpiriStat Corporate Capabilities
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2011 EmpiriStat Corporate Capabilities Document Transcript

  • 1. REACH  CLOSER  to  the  Truth   EmpiriStat, Inc.2011 Corporate Capabilities Summary BIOSTATISTICAL  SYNERGY   EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771 1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com  [1]
  • 2. EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 217711-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com  [2]
  • 3. Corporate Capabilities Summary REACH CLOSER to the Truth Quick Facts About  EmpiriStat,  Inc.   Woman-Owned Small EmpiriStat   was   founded   with   a   unique   goal:   to   discover   the   truth   as   far   as   Business possible.  As  biostatisticians  and  clinical  trialists,  we  believe  reaching  this  goal  is   only  possible  by  going  beyond  analytics.  For  every  research  and  development   Federalwide Assurance (FWA) A00015488 project,   science   and   fact   extend   along   a   timeline   in   both   directions—past,   present  and  future.  Applying  rigorous  methodologies  and  experience  at  every   CAGE Code: 53F97 point  along  this  timeline  results  in  outcomes  that  are  as  close  to  the  truth  as   DUNS Number: 826391034 possible.   Small Business NAICS codes:   518210 541519 541611 Our   work   lies   at   the   intersection   of   science   and   practice.   We   bring   in   depth   541690 541712 541720 experience   to   your   research   and   development,   along   with   accurate   541990 611420 611430 documentation,  rigorous  quality  control,  and  regulatory  compliance.  We  work   efficiently  under  tight  project  deadlines  without  compromising  quality.     EmpiriStat, Inc. Professional   Development and Training We   work   with   clients   interested   in   ongoing   communication   and   dialogue  Education and training is the between   disciplines   and   our   experience   comes   from   collaborating   with   many  cornerstone of EmpiriStat. researchers  over  a  wide  range  and  complexity  of  studies  in  epidemiology  and  Without the tools for continuous various   medical   and   device   specialties.   We   are   committed   to   providing   and  improvement professionally and maintaining  the  highest  scientific  rigor  and  ethical  standards—while  providing  personally, we believe we lose both  timely  and  cost-­‐effective  services.  the insight, knowledge, and  passion to further ourselves,our career, and our business. Commitment  to  Excellence  Training is the process of We   at   EmpiriStat   are   committed   to   “We have the passion fordeveloping specific skills to building   long   lasting   collaborative   making things happen with anperform a certain job or task relationships   with   our   clients.     We  more efficiently, and education urgent patience, optimism, and believe   that   to   forge   these   effective  is noted to be the overall relationships,   we   must   remain   true   to   a tolerance for uncertainty. It isdevelopment of the human our   key   values:   responsibility,   integrity,   not just the respect for ourmind. EmpiriStat offers a wide value,  and  commitment  to  excellence  in   knowledge in the field that werange of specific trainingsessions, such as Good Clinical every  role  and  task  we  undertake.     possess, but taking action andPractice (GCP) training, Site   doing valuable work with thatManagement Training, or Data Our  underlying  foundation  at  EmpiriStat   is   a   belief   that   we   can   make   a   knowledge.”and Safety Monitoring Board(DSMB) Training. We also offer difference   in   the   world   and   we   will   try  a wide variety of Professional to  do  that  each  and  every  day.  We  have   ~ Dr. Nicole Close, PresidentDevelopment courses, such as the   passion   for   making   things   happen,  Educational Modules in coupled   with   a   genuine   reserve   of   good   will,   from   professionals   who   are  Biostatistics for Non- excited  to  share  and  contribute  their  knowledge  and  experience,  but  who  are  Statisticians, Epidemiology, equally   compelled   to   learn   and   to   engage   themselves   in   that   process   to  Data Management, andPharmacovigilance. Please continually  improve  corporately,  professionally  and  personally.      contact us to request a  Professional Development andTraining Brochure.   EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771 1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com  [3]
  • 4. SELECTED CASE STUDIES Services  Challenge: A pharmaceutical We  offer  the  following  major  clinical  research  collaboration  and  services:  company was only months away Biostatistics  Statistical  Programming  from filing their NDA with the Data  and  Safety  Monitoring  Board  Services  FDA. They did not have an in- Project  Management    house Biostatistics/StatisticalProgramming group for review Statistical  Software  and  Programming  Validation  and writing of the ISS SAP and Clinical  Data  Management      to conduct the validation Clinical  Site  Management  programming for their program. Clinical  Monitoring  Services   Safety  Monitoring  and  Reporting  Services  Statistical Analysis: EmpiriStatcollaborated with the company Regulatory  Support  Services  and provided all of the services Scientific  Administrative  Support  required as the Sponsor’s in- Biostatistical  Synergy  house Biostatistics and Statistical  Programming group to support  both the ISS and the NDA filingwithin a very condensed Biostatistics  and  Statistical  Programming  timeframe without compromising EmpiriStat   provides   a   wide   range   of   services   throughout   every   project   and  quality. clinical  trial  phase.    Some  services  –  such  as  statistical  programming  of  tables,   listings,  and  figure  shells  –  provide  cost  and  time  savings  to  our  collaborator  if  Result: The company receivedthe Biostatistical guidance, programmed   and   validated   while   the   trial   is  writing, review and statistical ongoing  (instead  of  during  the  database  closure  and  validation programming from analysis  phase).    The  range  of  our  assistance  can  be  EmpiriStat to complete the filing categorized   loosely   by   project/trial   phase  within the existing company (Implementation,   Ongoing,   Database   Closure,  timelines. The company saved Analysis,  Post  Clinical  Trial,  and  General)  and  range  time and money by consulting from   hypothesis,   objectives   and   endpoint   planning,   Protocol   and   Statistical  with EmpiriStat who provided Analysis   Plan   writing/review,   Sample   size/power   calculations,   Statistical  flexible, time efficient and cost programming   specifications,   to   Interim   data   monitoring/analysis,   Database  effective services in an expedited review   and   cleaning,   and   Primary   statistical   analysis   and   secondary   review   of  manner set by the client’s needs. statistical  analysis  and  interpretation.    Challenge: The client hadcontracted with EmpiriStat for Data  and  Safety  Monitoring  Board  Services  part-time Senior Clinical and Establishing,   managing,   and   participating   on   a   Data   and   Safety   Monitoring  Regulatory Affairs Management Board   (DSMB)   is   a   serious   process.     EmpiriStat   has   the   skills,   knowledge,   and  and expertise. The client was experience   to   perform   DSMB   services   professionally   and   effectively.   As   a  also in the process of contracting partner  in  the  process,  we  assist  the  Sponsor  in  DSMB  member  identification  for a full service CRO to provide and   selection,   DSMB   training,   and   full   administrative   support   services.   Our  Data Management, Clinical professional   management   and   secure   data   analysis   and   delivery   ensures  Monitoring, Safety Reporting, leadership   to   assist   with   establishing   the   objectives,   responsibilities,   and  Biostatistics, and Regulatory procedures   through   an   official   charter.   We   also   have   the   expertise   to   establish  support for their multi-centerclinical trial. However, the client procedures   for   the   review   of   safety   data,   and   we   are   fully   qualified   to   act   as  was having contracting the   unblinded   partner   in   performing   the   statistical   analysis   and   facilitation   of  difficulties and the trial timelines the   exchange   of   information   between   the   DSMB   members,   DSMB   Chair,   and  were being delayed. Sponsor.      Solution: EmpiriStat wascontracted by the client to  expand their current services to  provide a Bridge until the CROcould be selected and  contracted. In a condensed EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771 1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com  [4]
  • 5. timeline of just 4 months,EmpiriStat created the Project  Management    deliverables and provided the EmpiriStat   has   the   experience   and   capability   to   succeed   at   collaborating   and  on-site professionals to initiate managing   overall   projects   and   clinical   trials   beyond   statistical   services.     We  the clinical trial (including have   the   ability   to   provide   critical   leadership   across   the   entire   project   team,  complete Case Report Forms, and   we   work   with   the   sponsor   to   complete   deliverables   and   strive   to   meet  Manual of Procedures, a Safety project   timelines   and   budget   specifications.     Our   Project   Management   support  Reporting System, Study Specific will   guide   your   study   with   seamless   communication   that   will   define   and  Procedures, Establishment and complete  your  project  on  time,  and  on  budget.    Some  of  our  PM  services  can  procedures for a Data and Safety include   “hands-­‐on”   oversight   from   concept   to   completion,   coordination   and  Monitoring Board, all training review  of  project  deliverables  such  as  Protocols,  CRFs,  and  other  clinical  study  modules, Clinical Monitoring Planand 2 certified research tools,  and  study  budget  forecasting  and  contract  negotiation.    We  also  develop  coordinators and one Risk   Analysis   Plans,   Outsourcing   Plans,   and   Contingency   Plans   to   reach   your  professional consultant). A clear project  milestones.  transition plan was developed  between EmpiriStat’s Bridge of  Statistical  Software  and  Programming  Validation  services to the CRO. Validation   is   a   critical   element   in   clinical   trials,   and   EmpiriStat   provides  Result: The client moved valuable   insight   for   the   entire   validation   process,   including   assistance   with  forward with the deliverables validation   procedures   and   documentation   of   statistical   software   installation,  required to initiate the trial operation   and   performance   qualification,   SAS®   Macro   and   statistical  without further delay, had no programming  validation,  and  independent  review  and  assessment  of  corporate  cost or delay associated with anew group getting up to speed statistical  software  validation  procedures,  processes  and  documentation.  on the trial since EmpiriStat was  currently providing management Clinical  Data  Management    guidance. It saved time and Effective  and  well-­‐executed  data  management  is  a  vital  part  of  any  project  or  money when the CRO was hiredsince all primary deliverables had clinical  trial,  and  EmpiriStat’s   Data  Management  services  been created for the study. ensure  the  quality  of  your  results.      EmpiriStat  is  capable   of  providing  full  data  management  services  to  include  the   design   and   review   of   case   report   forms,   Data  Challenge: A European device Management   Plans,   and   the   development   of   edit  company was preparing for filing specifications.     We   also   have   the   ability   to   develop   and  with the US FDA with a device implement   a   clinical   database   to   collect   and   store   study   data,   and   perform  already approved in Europe. medical  coding  using    MedDRA  and  WHO  Drug  dictionaries.  EmpiriStat  is  proud  They had consulted with an to   be   capable   of   supporting   studies   that   are   paper-­‐based,   electronic,   or   a  academic Biostatistician in the hybrid  of  both.  US, but were unsure of theanalyses and recommendations    that the Biostatistician had made Clinical  Site  Management  and was looking for an Selection,   evaluation   and   qualification   of   clinical   sites   and   investigators   are  independent senior statistical critical   for   the   successful   execution   and   completion   of   clinical   trials.   The   site  opinion. selection  process  and  the  relationship  of  the  sponsor-­‐site-­‐investigator  are  key  Solution: EmpiriStat was areas  of  opportunity  in  accelerating  the  drug  and  device  development  process  consulted to review the while   generating   high   quality   data.   Site   selection   is   a   crucial   decision   that  statistical analyses and needs   to   be   made   by   the   Sponsor   in   which   both   obvious   and   underlying  recommendations and to provide challenges   are   addressed   and   efficiencies   are   made.   Considerations   we   take  their own assessment prior tothe company filing. EmpiriStat into   account   are   the   potential   of   patient   recruitment   and   retention;   the  statisticians (PhD Biostatistician experience   of   the   site   Principal   Investigator,   quicker   start-­‐up   processes,   the  with US Regulatory experience increased   competition   among   Sponsors   for   sites,   patients,   increased  and an EmpiriStat UK Statistical globalization   of   trials   and   key   players,   and   FDA   and   international   regulations.    Consultants versed in EMEA EmpiriStat   assists   the   Sponsor   in   creating   site   selection   and   management  guidances) reviewed the processes  by  taking  an  in-­‐depth  look  at  specific  steps  and/or  a  critical  analysis  information and provided a of   existing   practices,   challenges   and   provide   an   opportunity   to   formulate   a   EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771 1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com  [5]
  • 6. detailed Statistical Risk Analysis more  solid  partnership  between  Sponsors,  sites  and  investigators.    of the filing.  Result: The device company Our   team   has   successfully   implemented   clinical   trial   sites,   and   we   have   proven  was provided with a detailed processes   for   starting   new   sites   that   remain   lasting   ones   through   in-­‐depth  Statistical Risk Analysis training,  education  and  continual  mentoring.  summary and an independent  assessment. The company mademodifications to their filing based Clinical  Monitoring  Services  upon EmpiriStat’s Frontline   attention   to   detail   and   quality   comes   from   well-­‐developed   clinical  recommendations and monitoring   plans   and   their   appropriate   execution.     EmpiriStat   embraces   the  successfully filed with the US philosophy   that   the   biostatistician   and   data   manager   works   with   the   clinical  FDA. monitor   in   those   plans   in   order   to   provide   insight   into   key   variables   and   issues   of  data  collection  and  recording  that  may  have  an  impact  on  the  final  analyses.     Early   identification   prevents   issues   later   and   saves   staff   time   and   costs.     We   Therapeutic Experience assist  our  collaborators  with  expertise  in  quality  assurance  of  study  operations,   • Infectious Diseases writing  and  implementing  clinical  monitoring  plans,  monitoring  reports,  as  well   • Vaccines as  protocol  and  regulatory  compliance  review.   • Traumatic Brain Injury It’s  our  standard  to  have  a  very  short  turnaround  time  for  issuing  our  reports.   • Transplants and Immunology Something  we  take  great  pride  in  and  have  been  commended  on  by  many  of   • Anti-Infectives • Reproductive Health our  clients.   • Medical Devices   • Dermatology Safety  Monitoring  and  Reporting  Services   • Blood Products EmpiriStat   offers   a   comprehensive   plan   to   help   you   manage   your   pre-­‐   and   • Wound Care • Oncology post-­‐marketed   product   safety   program.   This   management   and   services   may   • Diabetes include  Serious  Adverse  Event  (SAE)  and  Adverse  Event  (AE)  reporting,  SAE  and   • Cardiovascular Disease AE   MedDRA   coding,   examining   current   treatment   utilization   patterns,   SAE   narrative   writing,   submission   to   regulatory   authorities,   generation   of   MedWatch   (3500A/CIOMS)   Forms,   preparation   of   periodic   safety   update   reports   (PSURs)   and   periodic   adverse   drug   experience   reports   (PADERs.   We  Global Depth and Diversity follow   the   FDAs   Good   Pharmacovigiliance   Practices   and   EMEAs   European   • Government Directive  2001/20/EC  guidelines  and  focus  our  work-­‐products  on  the  end-­‐user   • Non Profit Organizations perspective.     • Private Industry For   those   studies   that   require   use   of   an   Independent   Safety   Monitor,   our   • Academic EmpiriStat  Consultants  stand  ready  to  perform  those  functions  as  well,  safely   partitioned  and  fire-­‐walled  from  our  Safety  Department  and  project  staff.   • Private Practices       Regulatory  Support  Services   “Empiristat  runs  a  client-­‐focused  business   EmpiriStat   offers   tailor   made   regulatory   services   to   assists   Sponsors   and   with  customer  satisfaction  and  quality  of  services  as  their  top  priorities.  They  serve  as   Investigators   with   the   administrative   activities   involved   in   meeting   the   the  protocol  statisticians  for  my  research   regulatory   requirements   for   research   involving   human   subjects.     We   can   studies,  participate  in  data  safety   assure   that   study   projects   and   protocols   comply   with   federal,   state,   and   monitoring  boards,  and  even  developed  a   institutional  requirements  governing  the  conduct  and  implementation  of  each   statistical  capacity-­‐building  workshop  for   trial,   and   can   serve   as   a   liaison   between   the   FDA,   the   IRB,   Investigators,   and   the  new  researchers  in  Africa  with  whom  I  work.  They  have  a  totally  positive  attitude— Research  Staff.    Additionally,  we  can  offer  consultation  and  guidance  regarding  and  are  efficient,  effective,  responsive,  and   the  application  to  the  FDA  regarding  your  product  or  device,  support  for  FDA   flexible.”   and   IRB   submissions,   assistance   with   registering   trials   on   ClinicalTrials.gov,     assistance   with   Pre-­‐IND   meetings,   Type   B   Meetings   and   other   regulated   ~Dr.  Judi  Chamberlin   U.S.  Military  HIV  Research  Program   meeting  requests,  and  guidance  for  FDA  audits.   Kisumu,  Kenya     EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771 1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com  [6]
  • 7.   Scientific  Administrative  Support   Often   it   is   necessary   to   provide   scientific   administrative   support   for   a   project   that   may   not   have   a   dedicated   individual   to   perform   these   services,   or   does   not  have  a  sufficient  amount  of  this  work  to  employ  a  full-­‐time  staff  member   to   handle.     This   often   results   in   these   services   being   assigned   to   members   of   the  team  with  other  duties.    With  competing  projects,  timelines,  and  efficiency   in   mind,   EmpiriStat   recognizes   these   challenges   and   provides   the   following   services  to  support  your  team:    Administrative  management  of  Data  and  Safety  For personalized attention Monitoring   Boards,   preparation   and   distribution   of   paper   and   electronic   contact us at: documents,   on-­‐site   management   of   local   or   international   conferences,   and   coordination   of   Investigator   kick-­‐off   meetings.   Also   provided   are   the   coordination   and   scheduling   of   science   team   meetings,   and   taking   minutes   EmpiriStat, Inc. during  these  group  collaborations.     13694 Sam Hill Drive Mount Airy, MD 21771   Tel: 866.935.STAT Biostatistical  Synergy     Fax: 866-.276.STAT derived  from  the  Greek  synergos,  συνεργός  meaning  working  together   Email: info@empiristat.com   Synergy  is  when  two  or  more  different  entities  cooperate  advantageously  for  a   final   outcome.     We   think   with   EmpiriStat’s   teamwork,   we   will   help   you   produce   an   overall   better   result   than   if   you   were   working   toward   the   same   goal   individually.   We   take   pride   in   our   ability   to   provide   the   highest   quality   services   with   an   appropriately   staffed   team   while   maintaining   our   responsiveness   and   flexibility   of   a   smaller   company.   It’s   a   promised   standard   from   us   that   includes   expertise,   mentoring,   and   support   from   a   team   of   experts  who  understand  your  needs.  Our  goal  is  always  to  help  you  succeed  by   www.empiristat.com working  as  a  part  of  your  team.  We  will  tailor  a  project  plan  to  meet  the  needs   of   every   project,   whether   you   need   full   scope   global   services   or   only   one   particular   service,   such   as   statistical   analysis   and   programming.   It   is   our   absolute   goal   to   help   you   succeed   by   fully  integrating   and   working   as   part   of   your  team.         “I’d  heard  Empiristat  would  be  a  good  company  to  handle  our   statistical  analysis.  They  were  very  patient  while  we  waited  for   regulatory  clearance,  then  incredibly  fast  and  efficient  when   clearance  finally  came.  Their  data  cleaning  was  nothing  short  of   amazing,  and  when  I  asked  them  on  short  notice  to  write  some   abstracts  for  conferences,  I  was  blown  away  by  how  quickly  this   was  done—and  they  were  extremely  well-­‐written.    I  can’t  say   anything  bad  about  Empiristat.”     ~Mark  Breda   Makerere  University  School  of  Medicine   Kampala,  Uganda   EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771 1-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com  [7]
  • 8. EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 217711-866-935-STAT or 240-744-0000  Fax 866-276-STAT  www.empiristat.com  [8]