Confidential and in confidence

Customer Briefing

30th April 2014

Peter Watts

THIS DOCUMENT AND THE INFORMATION AND DATA IN IT ARE PRIVILEDGED AND CONFIDENTIAL. THEY ARE PROVIDED IN CONFIDENCE, FOR THE SOLE PURPOSE OF EVALUATING THE CLINICAL CUBE OFFER AND MAY NOT BE DISCLOSED TO ANY THIRD PARTY OR USED FOR ANY OTHER PURPOSE WITHOUT THE EXPRESS WRITTEN PERMISSION OF THE CEO OF CLINICAL CUBE LIMITED.

Confidential and in confidence

Clinical  Cube  deploys  data  and  technology  that  expedites  and  transforms  the  five  stages  of  clinical  trials  and  related  drug  development  processes.  Our  solu;on  allows  us  to  process  and  dis;ll  massive  amounts  of  standard  and  non-­‐standard  observa;onal  and  clinical  data.      

Proprietary  data  extrac;on  capabili;es  allow  us  to  turn  data  into  knowledge,  deliver  focused  reports  and  run  unique  pa;ent  recruitment  and  monitoring  processes  on  behalf  of  our  clients.      

Proposi;on  

Confidential and in confidence

Current  prac;ce  

Random  

Clinical  Cube  

Precise  

•  Clinical  Cube  replaces  current  fragmented  &  inefficient  processes  with  an  ultra  efficient  data  &  technology  solu;on  

•  Our  managed  service  provides  immediacy  and  accuracy,  removing  the  arbitrary  nature  of  manual  legacy  clinical  data  collec;on  solu;ons    

Unique  Proposi;on  

Confidential and in confidence

•  CC//DATA  is  the  central  data  warehouse  that  drives  all  of  Clinical  Cube’s  individual  product  solu;ons.  

•  Real  world  health  and  demographic  data  combines  with  primary  and  secondary  care  health  data  sources  to  build  the  core  of  Clinical  Cube’s  analy;cal  services    

 CC//DATA  

CC//DATA  

CC//  Feasibility  

CC//RECRUITMENT  

CC//  REPORTER   Clinical Cube

Product portfolio

Confidential and in confidence

All  repor;ng  and  analysis  is  developed  in  collabora;on  with  our  customers  and  the  outputs  are  unique  in  regard  to  their  specific  needs.    Typically  these  reports  include  the  following:    

Report  and  analysis  

• Prevalence  by  geography  -­‐  produced  na;onally,  regionally  and  by  surgery.    • Prevalence  by  hospital  –  surgeries  linked  to  hospital  by  radius    • Disease  incidence  by  hospital  • Loca;on  –  geographical  analysis  of  trials  by  loca;on  showing  phase  of  trial,  therapeu;c  area,  recruitment  target  and  recruitment  status  

Feasibility  

• Na;onal  prevalence  review  and  locality  hotspot  iden;fica;on  • Aggregated  (non  PCD)  subject  data  extracted  from  GP  systems*    • Individual  subject  data  (PCD)  extracted  from  GP  systems  *  

Recruitment  

• Aggregated  (non  PCD)  subject  data  extracted  from  GP  systems,  weekly,  monthly  quarterly  *  • Individual  subject  data  (PCD)  extracted  from  GP  systems  *  • Safety  and  surveillance  reports  *  • Excep;on  and  adverse  events  repor;ng  *  • Quality  of  life  reports  *  

Reporter  

•  Clinical Cube, under IGSoC governance standards, will support appropriation of data extraction agreements with GP’s, Investigators and patients

Confidential and in confidence

•  The  impera;ve  to  be  agile  and  accurate  in  delivering  trial  feasibility,  at  all  phases  of  development,  has  never  been  greater.  Speed  and  precision,  combined,  offer  the  key  to  expedi;ng  drug  development  ;mescales  and  improving  related  ROI.  

•  CC//Feasibility  is  used  to  address  feasibility  analysis  at  the  outset  of  trial  development,  Phase  0,  and  throughout  phases  II,  III  and  IV  of  the  trial  development  process.  

•  Combining  UK  observa;onal  health  data  with  other  related  informa;on  sets  allows  our  systems  and  analysts    to  work  hand-­‐in-­‐hand  with  our  customers  to  be_er  inform  and  accelerate  the  feasibility  and  assessment  stages  of  all  phases  of  the  drug  development  process.  

 

CC/FEASIBILITY  

Confidential and in confidence

CC/FEASIBILITY  •  CC/Feasibility  uses  the  latest  Geo-­‐mapping  tools  to  iden;fy  pa;ent  cohorts  

across  the  country  using  the  trial  protocol  to  define  the  search  algorithm  

•  Once  na;onal  pa_erns  have  been  iden;fied  data  can  be  interrogated  at  a  local  surgery  surgery  level  

 

Confidential and in confidence

Confidential and in confidence

•  Pa;ent  recruitment  remains  one  of  the  most  challenging,  ;me  consuming  and  costly  aspects  of  any  trial.  Without  high  quality  search  and  selec;on  at  the  beginning  of  a  project,  the  results  can  ocen  lead  to  poor  reten;on,  project  delays  and  at  worst  trial  failures.  

•  Working  within  stringent  and  approved  data  governance  prac;ces,  CC//Recruitment  u;lises  CC//Data  to  deliver  a  3  step  process  that  allows  a  trial  organisa;on  to  iden;fy  likely  pa;ent  groups,  provide  access  to  pa;ents  with  the  support  of  their  GP  and  finally  provide  onward  pa;ent  contact  management.  

•  Using  our  unique  data  driven  approach,  CC//Recruitment  removes  the  arbitrary  nature  of  clinical  trial  pa;ent  enrollment.  Our  collabora;ve  approach  combines  the  interests  of  the  trial  organisa;on,  inves;gator  site  and  pa;ent  to  bring  a  new  level  of  proficiency  to  the  development  and  delivery  of  clinical  trials.    

 

CC//RECRUITMENT  

Confidential and in confidence

•  Iden;fy  simple  and  complex  pa;ent  types  using  mul;ple  indicators.  Accurate  selec;on  ensures  faster  recruitment  and  lower  fall  out  rates    

•  Conduct  what-­‐if  analysis  to  build  around  centres  of  excellence  

•  Focus  CRA  ac;vity  

•  Lower  trial  failure  rate  

•  Reduce  costs  

•  Focused  results  

CC//RECRUITMENT  

Confidential and in confidence

•  Access  to  data  to  support  observa;onal,  registry  and  health  outcomes  is  of  immense  importance  to  achieve  a  robust  and  high  quality  outcome.    Direct  access  to  real  world  data  presents  poten;ally  significant  ;me  and  cost  savings  compared  to  the  more  tradi;onal  routes  of  achieving  data  collec;on.  

•  U;lising  granular  level  data,  including  quality  of  life  results,  enables  us  to  support  the  requirement  to  provide  ongoing  assessment  and  analysis  of  cri;cal  success  factors,  support  evalua;on  of  benefit-­‐risk  data  as  well  as  deliver  the  post  marke;ng  safety  surveillance  remit  required  by  regulators.  

•  Data  immediacy  is  central  to  our  solu;on.  CC//Repor;ng  ensures  that  our  customers  have  speed  of  access  and  a  degree  of  data  transparency  that  will  allow  them  to  transform  their  own  repor;ng  capabili;es.  Improving  quality  and  improving  outcomes.  

 CC//REPORTING  

Confidential and in confidence

•  Na;onal  pa;ent  cohorts  can  be  recognised  and  analysed.    

•  Each  group  or  individual  can  be  managed    and  analysed  on  an  ongoing  basis.  

•  Surveillance,  excep;on  repor;ng  and  QOL  can  be  monitored  on  an  ongoing  basis  

 CC//REPORTING  

Confidential and in confidence

Thank You

Peter Watts e. peter.watts@clinical.cube.com t. 07776 131954

THIS DOCUMENT AND THE INFORMATION AND DATA IN IT ARE PRIVILEDGED AND CONFIDENTIAL. THEY ARE PROVIDED IN CONFIDENCE, FOR THE SOLE PURPOSE OF EVALUATING THE CLINICAL CUBE OFFER AND MAY NOT BE DISCLOSED TO ANY THIRD PARTY OR USED FOR ANY OTHER PURPOSE WITHOUT THE EXPRESS WRITTEN PERMISSION OF THE CEO OF CLINICAL CUBE LIMITED.